Exactech 170-32-93Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862153647), received between Sep 5, 2022 and Jan 27, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, METAL RELATED PATHOLOGY, DISCOMFORT, SYNOVITIS, AND PAIN. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Metal Related Pathology; Pain; Synovitis

  MAUDE report 21243942 ↗
• InjuryOct 3, 2024Naturally Worn; Naturally Worn

  01-OCT-2024 ADDITIONAL INFORMATION" LEGAL CASE ¿ USA (MDL NO. 3044) PATIENT ID: (B)(6) + RIGHT HIP CASE-(B)(4) HIP (UNKNOWN SIDE) IS ASSOCIATED WITH THIS CASE. IT IS REPORTED VIA LEGAL DOCUMENTATION THE PLAINTIFF UNDERWENT RIGHT HIP REPLACEMENT (B)(6) 2015 AND UNDERWENT REVISION RIGHT HIP (B)(6) 2024 (SHORT FORM COMPLAINT ATTACHED). THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1732-2022 130-32-51 - NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS SERIAL: (B)(6) 510K:

  Patient problems: Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20358640 ↗
• InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY NINE MONTHS POST INITIAL THA, THIS 69 Y/O FEMALE PATIENT HAD A REVISION FOR AN UNKNOW REASON NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15355429 ↗