Acetabular Insert 2099-2861Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327031591), received between Nov 21, 2023 and Nov 21, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗