Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-03-20Open, ClassifiedNonconforming Material/Component

  Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627

  Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

• 2024-01-12Open, ClassifiedDevice Design

  PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615, BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815, BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865, BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620, BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820, BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870

  Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.

• 2023-06-27Open, ClassifiedDevice Design

  REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R

  Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

• 2023-06-27Open, ClassifiedDevice Design

  REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

  Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

• 2023-04-01Open, ClassifiedProcess control

  SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

  Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.

• 2020-03-03TerminatedUnder Investigation by firm

  Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.

  A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

• 2015-06-11TerminatedLabeling mix-ups

  Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.

  Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

• 2009-09-04TerminatedRelease of Material/Component prior to receiving test results

  Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene liner. DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the indications for use.

  Product devices used for testing are not identical to what was manufactured. Under certain circumstances snap feature could allow poly liner to move on baseplate reducing tightness of fit.

• TerminatedLabeling False and Misleading

  COMP PRIMARY STEM 8MM MINI, model # 113628

  Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

• TerminatedEnvironmental control

  Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

  Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.