Acetabular InsertRecalls & reported problems across all models

We found 7 models of Acetabular Insert by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2018 and Apr 26, 2024 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Acetabular Insert recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 30, 2026Open, Classified

   Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

   Z-3201-2026 · Root cause: Process change control · names 4 of these models · Recall details · FDA record ↗

Most reported Acetabular Insert problems

Acetabular Insert models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Acetabular Insert 2099-2250

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  1 recall2 reports
• Acetabular Insert 2099-2252

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  1 recall1 report
• Acetabular Insert 2099-2861

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  1 recall1 report
• Acetabular Insert 2099-2256

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  1 recall0 reports
• Acetabular Insert 2099-2254

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  3 reports
• Acetabular Insert 2099-2258

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  2 reports
• Acetabular Insert 2099-2858

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  2 reports

Recent Acetabular Insert adverse event reports

The 11 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION OF THE INNER BIPOLAR COMPONENT FROM THE OUTER COMPONENT OF A CONSTRAINED LINER. THE LINER AND FEMORAL HEAD WERE REVISED TO ANOTHER CONSTRAINED LINER AND FEMORAL HEAD. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 19195550 ↗
• InjuryNov 21, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S HIP WAS REVISED. COMPARING WITH THE USAGE SHEET FROM A PRIOR REVISION, A 28 +5 FEMORAL HEAD AND CONSTRAINED INSERT WERE REVISED TO A 28 +10 FEMORAL HEAD, CONSTRAINED INSERT, AND 2 ADDITIONAL SCREWS. ADDITIONAL INFORMATION AS PER SALES REP, "RECURRING INSTABILITY AND IMPLANT WEAR. HEAD AND LINER WAS EXCHANGED A MONTH PRIOR AND GOT INFECTED. WENT BACK IN TO REPLACE HEAD AND LINER AGAIN."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 18180094 ↗
• InjuryNov 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2022. ORIGINALLY REPORTED: "DISLOCATIONS IN A PATIENT AFTER UNDERGOING TOTAL HIP REPLACEMENT SURGERY WITH STRYKER PRODUCTS." RECORDS AND INFORMATION PROVIDED BY LITIGATION COORDINATOR INDICATE THE FOLLOWING PATIENT HISTORY: PRIMARY LEFT HIP IMPLANTATION APPROXIMATELY (B)(6) /2010. REVISION ON (B)(6) 2011 WITH A HEAD AND LINER EXCHANGE. REVISION (B)(6) 2014 DUE TO DISLOCATION, LINER WAS EXCHANGED. REVISION (B)(6) 2022, A CONSTRAINED LINER WAS CEMENTED INTO THE PATIENT. REVISION (B)(6) 2022, ALL STRYKER COMPONENTS REMOVED AND A COMPETITOR HIP WAS IMPLANTED. PER THE LITIGATION COORDINATOR, THE PATIENT IS REFUSING TO PROVIDE ANY ADDITIONAL INFORMATION BEYOND WHAT IS CURRENTLY PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 15885785 ↗
• InjuryNov 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2014. ORIGINALLY REPORTED: "DISLOCATIONS IN A PATIENT AFTER UNDERGOING TOTAL HIP REPLACEMENT SURGERY WITH STRYKER PRODUCTS." RECORDS AND INFORMATION PROVIDED BY LITIGATION COORDINATOR INDICATE THE FOLLOWING PATIENT HISTORY: PRIMARY LEFT HIP IMPLANTATION APPROXIMATELY ON (B)(6) 2010. REVISION ON (B)(6) 2011 WITH A HEAD AND LINER EXCHANGE. REVISION 11/MAY/2014 DUE TO DISLOCATION, LINER WAS EXCHANGED. REVISION ON (B)(6) 2022, A CONSTRAINED LINER WAS CEMENTED INTO THE PATIENT. REVISION ON (B)(6) 2022, ALL STRYKER COMPONENTS REMOVED AND A COMPETITOR HIP WAS IMPLANTED. PER THE LITIGATION COORDINATOR, THE PATIENT IS REFUSING TO PROVIDE ANY ADDITIONAL INFORMATION BEYOND WHAT IS CURRENTLY PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 15885773 ↗
• InjuryOct 17, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A LEFT HIP ACETABULAR REVISION DUE TO RECURRENT DISLOCATION/DISASSOCIATION.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15613312 ↗
• InjuryJan 15, 2021Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION. COMPARING THE CURRENT AND PREVIOUS REVISION USAGE SHEETS, A CONSTRAINED LINER, FEMORAL HEAD, AND RESTORATION MODULAR PROXIMAL BODY WERE REVISED TO A RESTORATION MODULAR PROXIMAL BODY, CERAMIC V40 HEAD, AND CONSTRAINED LINER.

  Patient problems: Joint Dislocation

  MAUDE report 11178324 ↗
• InjurySep 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE COMPLAINT OF ACHING AFTER REVISION. PATIENT'S DAUGHTER SUPPLIED OPERATIVE REPORTS, EXAM AND CLINIC NOTES, X-RAYS AND X-RAY REPORTS, AND A PATIENT LETTER ADDRESS TO STRYKER FOR A (B)(6) 2017 LEFT HIP REVISION AND A (B)(6) 2017 HIP REVISION. IN THE LETTER, DATED 14/JULY/2019, THE PATIENT STATES "FOR A VERY LONG TIME THERE WAS A SORENESS IN THE AREA ALONG THE PATH IT [BROKEN RING OF CONSTRAINED LINER, PORTION MIGRATED FEMORALLY] HAD MOVED DOWN LEG. TODAY IT STILL ACHES A LOT. THE INCISION SCAR IS SO DEEP".

  Patient problems: Pain; Scarring

  MAUDE report 8955489 ↗
• InjuryAug 15, 2019Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE CONSTRAINED LINER OUT OF THE ACETABULAR SHELL. INTRA-OPERATIVELY, THE METAL RING OF THE CONSTRAINED LINER WAS REPORTED AS BROKEN ("SNAPPED"), AND THE INNER EDGE OF THE SHELL WAS REPORTED AS BEING ASSYMETRIC DUE TO WEAR. A 54MM SERIES II ACETABULAR SHELL, 50MM HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT, AND STRYKER FEMORAL HEAD WERE REVISED TO A TRIDENT II SHELL WITH 6 SCREWS, A TRIDENT CONSTRAINED LINER, AND ANOTHER STRYKER FEMORAL HEAD. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE FEMORAL HEAD. THE EXPLANTS ARE AVAILABLE FOR RETURN. OTHERWISE, REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8897456 ↗
• InjuryApr 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BHA WAS DONE WITH NON STRYKER STEM AND BIPOLAR CUP ABOUT 8 YEARS AGO. THE HEAD AND CUP WAS DISLOCATED AND REVISON SURGERY WAS DONE WITH CONSTRAINED LINER AT (B)(6) 2019. STEM AND HEAD WAS NOT CHANGED. AT (B)(6) 2019, IT WAS DISLOCATED AND STEM WAS REMOVED. THE PATIENT HAD PARALYSIS AND BEDRIDDEN. THE REVISION SURGERY WAS NOT PLANED AT THIS TIME.

  Patient problems: Injury

  MAUDE report 8505919 ↗
• InjuryNov 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "EVENT: PATIENT'S CONSTRAINED LINER DISLOCATED. CONSTRAINED LINER/ SHELL WERE REMOVED AND CONSTRAINED LINER IMPLANTED". UPDATE 25/OCTOBER/2018: REP REPORTED THE FOLLOWING: THE BIPOLAR DISLOCATED OUT OF THE LINER. CONSTRAINED LINER WAS SECURELY LOCKED IN SHELL. NEW HEAD WAS IMPLANTED INCREASING LENGTH FROM +0 TO +8. SURGEON CHOSE TO REVISE SHELL TO NEW TRITANIUM REVISION SHELL. OLD SHELL CAME OUT EASILY. NO POSSIBLE CAUSES FOR DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8090185 ↗
• MalfunctionAug 16, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  REP PROVIDED A USAGE SHEET WHICH SHOWED A SERIES II LINER AS WASTED. REP REPORTED THAT THE SURGEON HAD TRIED THAT LINER FIRST, BUT IT WASN'T STABLE. SURGEON THEN TRIED THE SECOND LINER ORIGINALLY REPORTED. A SCREW, ALSO WASTED, WAS ONLY USED TO REMOVE THE 2 REPORTED LINERS. UPDATE 26-JUL-2018: REP ADDRESSED THE REPORT OF THE SERIES II LINER BEING UNSTABLE: "THE INSTABILITY WAS RELATED TO THE ROM AND LIKELY ASSOCIATED TO THE PATIENTS SOFT TISSUE ANATOMY FROM REVISION SURGERY. IT WAS NOT RELATED TO THE IMPLANT". THE SERIES II IMPLANT WAS DISPOSED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7788317 ↗

Other Howmedica Osteonics Corp. products

• Triathlon608 models · 3,524 reports · 15 recalls
• Scorpio107 models · 113 reports · 28 recalls
• Trident160 models · 1,280 reports · 2 recalls
• Accolade57 models · 1,228 reports
• Duracon58 models · 65 reports · 16 recalls
• LFIT23 models · 852 reports
• TRIDENT II42 models · 188 reports · 12 recalls
• INSTRUMENT131 models · 290 reports · 7 recalls