RECLAIM 1977-20-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295077275), received between Sep 22, 2021 and Jan 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2023Difficult to Remove; Difficult to Remove

  REVISION OF A C-STEM. FEMALE. LEFT SIDE. THE REASON FOR REVISION WAS DUE TO A PERIPROSTHETIC FRACTURE. PATIENT HAD A FALL. THE C-STEM AND HEAD WERE REMOVED, AND RECLAIM WAS IMPLANTED. DURALOC CUP AND LINER WERE LEFT IN SITU. STRYKER (DALL-MILES) CABLES WERE USED FOR CLOSURE OF PROXIMAL BONE. IT WAS ALSO CHALLENGING TO REMOVE THE POLY TAPER PROTECTOR FROM THE RECLAIM STEM 1977-20-190 LOT 651324. THIS ADDED A 5MIN DELAY TO REMOVE. THE PATIENT HAD A REVISION ON (B)(6) 2022 WHERE THE CHARNLEY ELITE STEM, HEAD, AND DURALOC LINER WERE REMOVED. THE REASON FOR THIS REVISION WAS DUE TO POLY WEAR WHICH HAD CAUSED THE STEM TO LOOSEN, AND CAUSED SIGNIFICANT BONE LOSS. A C-STEM WAS IMPLANTED, AND POLY WAS REPLACED WITH A MARATHON POLY. STRYKER CABLES (DALL-MILES) WERE ALSO USED.

  Patient problems: Fall; Limb Fracture

  MAUDE report 16213849 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY : DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR MASS IN RT POSTERIOR THIGH, HAMSTRING REGION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT (CUP): (B)(6) 2003. DATE OF IMPLANT: (B)(6) 2012. DATE OF EVENT: (B)(6) 2021. (RIGHT HIP). TREATMENT: DIAGNOSTIC MRI.

  Patient problems: Cyst(s); Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 12512571 ↗

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-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
• 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-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