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MAYClass 2

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

FDA adverse event reports and recall history for prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish (product code MAY), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
499
Deaths
0
Injuries
279
Malfunctions
200

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 20122026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2016-02-25TerminatedUnder Investigation by firm

    Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.

    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

  • 2016-02-25TerminatedUnder Investigation by firm

    Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

  • 2016-02-25TerminatedUnder Investigation by firm

    Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

  • 2016-02-25TerminatedUnder Investigation by firm

    Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

  • 2016-02-25TerminatedUnder Investigation by firm

    Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

  • 2016-02-25TerminatedUnder Investigation by firm

    Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

  • 2016-02-25TerminatedUnder Investigation by firm

    Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

  • 2016-02-25TerminatedUnder Investigation by firm

    Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

  • 2016-02-25TerminatedUnder Investigation by firm

    Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

  • 2016-02-25TerminatedUnder Investigation by firm

    Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

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