RECLAIM 1977-22-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295077336), received between Aug 29, 2017 and Nov 15, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K102080); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED FOR PAINFUL BIPOLAR COMPONENT. THE STEM WAS FOUND TO BE LOOSE AND WAS REVISED TOO. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20693452 ↗
• InjuryJul 27, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT HAD APPEARED THAT THE STEM HAD SUBSIDED AND WAS CAUSING CONCERN. THE SURGEON REVISED BY TAKING OUT ALL IMPLANTS AND REVISING TO A LARGER DIAMETER RECLAIM STEM, A NEW CUP WITH A CONSTRAINED LINER. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12235373 ↗
• MalfunctionMar 27, 2021Difficult to Open or Remove Packaging Material; Appropriate Device Problem Term/Code Not Available; Difficult to Open or Remove Packaging Material; Appropriate Device Problem Term/Code Not Available

  OPERATION WAS GOING WELL. SURGEON HAD SELECTED DESIRED IMPLANTS. IMPLANTS OPENED THE TAPER PROTECTOR COVER WAS IMPOSSIBLE TO REMOVE FROM THE STEM, THE SURGEON USED SEVERAL DIFFERENT METHODS TO REMOVE FROM GENTLY TRYING TO PRISE IT OFF TO BRUTE FORCE AND EVEN SLICING THROUGH IT WITH A SCALPEL. THE COVER WAS IMPOSSIBLE TO REMOVE. THE ITEM WILL BE AVAILABLE FOR INVESTIGATION ONCE IT HAS BEEN DECONTAMINATED. THE OPERATION WAS DELAYED FOR 15 MINS, THERE WAS NO HARM TO THE PATIENT. ANOTHER SAME SIZED STEM WAS AVAILABLE. AND THE CASE PROCEEDED WITHOUT FURTHER ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11579306 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FEMUR FRACTURE, INTRAOPERATIVE: PERIPROSTHETIC FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT HIP). TREATMENT: OPEN REDUCTION INTERNAL FIXATION WITH SYNTHES CERCLAGE CABLES X 3.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10792083 ↗
• InjuryAug 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. IT WAS STATED THAT THE SURGEON PULL OUT ALL IMPLANTS AND PUT IN A PROSTALAC HIP.

  Patient problems: Unspecified Infection

  MAUDE report 6829309 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102080. One submission often covers many models, so check the product and lot details in each record.

• Z-2083-2014 · Jun 3, 2014 · Terminated
  RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking ta
• Z-2082-2014 · Jun 3, 2014 · Terminated
  RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during
• Z-2084-2014 · Jun 3, 2014 · Terminated
  RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surf