RECLAIM 1977-27-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295077459), received between Oct 29, 2020 and Oct 29, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO STATED THAT THE STEM SPUN AND SUBSIDED BECAUSE IT WAS LOOSE. THE PATIENT HAS HAD MULTIPLE REVISIONS SO BONE QUALITY WAS A MAJOR ISSUE. SO THE SURGEON REMOVED THE STEM AND PLACED IN THE 31MM RECLAIM. HE ALSO REPLACED WITH A NEW POLY AND HEAD AS WELL. DOI: (B)(6) 2018. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10755717 ↗

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