RECLAIM 1976-17-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295077053), received between Aug 18, 2017 and Oct 20, 2022 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PLASTIC COVER THAT GOES OVER THE RECLAIM STEM TAPER HAS HAD TO BE CHISELLED AND CUT OFF DURING THIS PROCEDURE. IT CLEARLY SAYS ON THE ITEM TO ¿REMOVE AFTER REAMING¿ BUT DESPITE AN EXPERIENCED SCRUB MEMBER SUGGESTING WE REMOVED IT, THE SURGEON WHO IS FAIRLY NEW TO THE PROCEDURE, AS AM I, REFUSED TO TAKE IT OFF AS IT CLEARLY STATED TO LEAVE IT ON. HAVING REAMED OVER THIS USING THE 20MM PROX DRILL, THEY WERE STRUGGLING TO SINK IT FAR ENOUGH, DUE TO THE PLASTIC, SO ATTEMPTED TO REMOVE IT, BUT IT WOULDN¿T BUDGE. WE HAD NO SPARE STEM, AND WERE ACTUALLY UNABLE TO REVERSE THE STEM AS IT WAS STUCK IN SO WELL. LUCKILY AFTER 20 MINUTES OF TRYING WE WERE ABLE TO CUT IT OFF, BUT THE SURGEONS WERE 2 MINUTES AWAY FROM CONVERTING TO AN ETO IN ORDER TO REMOVE THE WHOLE STEM WHICH WOULD HAVE HAD A MASSIVE IMPLICATION ON THE PATIENTS RECOVERY. FORTUNATELY THE ONLY OUTCOME WAS AN EXTENDED LENGTH OF SURGERY, FOR WHICH NOTHING HAPPENED TO THE PATIENT WHILE ON THE TABLE BUT WE ARE UNABLE TO QUANTIFY THE EFFECTS LONG-TERM. HAVING SPOKEN TO A COLLEAGUE AFTER THE PROCEDURE, I WAS TOLD THESE IMPLANTS WERE OLD AND NOT ALL HAD THE TAPER COVER ON THEM. MY THOUGHT, AND THE SURGEONS ALSO,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638158 ↗
• MalfunctionDec 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECLAIM DISTAL STEM IMPLANT SUBSIDED PAST FINAL REAMING POSITION CAUSING THE OUTCOME TO NOT BE AS TRIALED TO PROVIDE SURGEONS EXPECTED CLINICAL OUTCOME. DOE: (B)(6) 2021. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916155 ↗
• InjuryJan 25, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH A RIGHT PERI-PROSTHETIC HIP FRACTURE THAT WAS ALSO INFECTED. REMOVED ALL RECLAIM AND PINNACLE IMPLANTS AND WIRED UP FEMUR AND IMPLANTED A PROSTALAC STEM AND CUP. THE STEM WAS LOOSE AT THE BONE TO IMPLANTED INTERFACE BECAUSE OF THE FRACTURE.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 8277185 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7969138 ↗
• InjuryJun 12, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Foreign Body In Patient; Inadequate Osseointegration; Not Applicable

  MAUDE report 7593537 ↗
• InjuryApr 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT'S INFECTED REVISION HIP WAS REMOVED AND THEN REPLACED WITH A PROSTALAC HIP UNTIL THE INFECTION IS CLEAR. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7435888 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FEMUR FRACTURED AND 4 CONTROL CABLES HAD TO BE USED.

  Patient problems: Bone Fracture(s)

  MAUDE report 6805117 ↗

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