NA 11910Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556008775), received between Oct 21, 2019 and Dec 20, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K072817, K211176); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BIP SURGERY PERFORMED ON (B)(6) 2012, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 FOR CONVERSION TO THA BECAUSE OF OA PROGRESSION ON THE ACETABULAR SIDE. AN UNIVERSAL FEMORAL HEAD COBALT CHROME 26MM 0MM EXTENSION WAS REPLACED WITH AN OXINIUM HEAD. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Arthritis

  MAUDE report 13043155 ↗
• InjuryOct 11, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A PARTIAL HIP REPLACEMENT SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT HAD TO UNDERGO A REVISION SURGERY ON (B)(6) 2021 DUE TO PAIN, LOOSENING, AND DISLOCATION. PATIENT OUTCOME REMAINS UNKNOWN.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 12603046 ↗
• InjuryFeb 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN, FEVER, SWELLING, AND FRACTURE.

  Patient problems: Injury; Pain

  MAUDE report 9687250 ↗
• InjuryOct 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. DEVICES EXPLANTED: REFLEXTION XLPE 26 0 DEGREES 54-56 SIZE F (71333365), UNIV COBALT CHROME 10/12 TAPER FEM HD 26MM 0 EXT (11910), SYNERGY SELECT PORAS STEM SIZE 14 (71305014) AND REFLECTION FSO SHELL V 56MM (71330056). DEVICES IMPLANTED: OX HEAD AND REFLEXION LINER. PRE-EXISTING CONDITIONS: OSTEOARTHRITIS.

  Patient problems: Injury

  MAUDE report 9216055 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072817, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.