UHR UH1-50-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327017076), received between Jul 19, 2017 and Aug 19, 2021 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BIPOLAR HEAD DISASSOCIATED FROM STEM AND FEMORAL HEAD CONSTRUCT DURING A WATER SKIING FALL. UPDATE: THE PATIENT WAS REVISED ON (B)(6) 2021.

  Patient problems: Discomfort

  MAUDE report 12344945 ↗
• MalfunctionOct 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT A CURVE METAL OBJECT WAS DETECTED THROUGH POST-OP X-RAY AND CT SCAN AFTER PATIENT WENT THROUGH A BIPOLAR HEMIARTHROPLASTY SURGERY. THE OBJECT IS LOCATING NEAR TO STRYKER UHR BIPOLAR COMPONENT AND FEMORAL METAL HEAD. PATIENT DOES NOT HAVE ANY COMPLICATION. THE OBJECT MIGHT AFFECT THE OPERATED JOINT ARTICULATION IN FUTURE. SURGICAL TEAM IS OBSERVING THE PATIENT FOR NEXT 3 MONTHS. DATE OF THE BIPOLAR HEMIARTHROPLASTY SURGERY: (B)(6) 2020. AS PER SALES CONFIRMATION, HOSPITAL IS NOT ABLE TO PROVIDE THE ADDITIONAL INFORMATION SUCH AS X-RAY PHOTO, DUE TO PDPA IN THE COUNTRY.

  Patient problems: Insufficient Information

  MAUDE report 10703823 ↗
• InjuryJul 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT HAD A BIPOLAR SURGERY ON (B)(6) 2019. HOWEVER, ON THE FOLLOWING DAY ((B)(6) 2019), THE SALES REPRESENTATIVE WAS CONTACTED BY THE SURGEON, STATING THAT THE HIP DISLOCATED AND WAS IRREDUCIBLE. HENCE, THE REVISION SURGERY WAS CARRIED OUT. THE BIPOLAR SURGERY WAS REVISED TO MDM, 52 MM TRITANIUM CUP, AND EXETER 35.5 STEM.

  Patient problems: Injury

  MAUDE report 8781873 ↗
• InjuryApr 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR REVISION OF PATIENT'S RIGHT HIP ON (B)(6) 2019. AS REPORTED: "RECENTLY REVISED PATIENT ((B)(6) 2019) PRESENTED WITH DISSOCIATED AND DISLOCATED UHR BIPOLAR CONSTRUCT. LFIT 28MM V40 HEAD REMAINED ATTACHED TO TRUNNION OF EXISTING ACCOLADE C STEM, HOWEVER 50/28 BIPOLAR HEAD WAS DISSOCIATED FROM INNER HEAD AND DISLOCATED FROM ACETABULUM. SURGEON CLAIMED "INNER RING" OF UHR HEAD WAS "CRACKED" BUT ATTEMPTED TO RE-ASSOCIATE THE EXPLANTED 28MM LFIT HEAD BEFORE PICTURES COULD BE TAKEN. REVISION WAS DEEMED AS NECESSARY DUE TO INSTABILITY; SURGEON DEEPENED THE NATIVE ACETABULUM AND REPLANTED A 50MM UNITRAX COMPONENT WITH +4MM V40 SLEEVE. AWAITING RETURN OF EXPLANTED IMPLANTS FROM HOSPITAL DECONTAMINATION". UPDATE (B)(6) 2019: SPOKE TO REP. NO POSSIBLE CAUSE OR CONTRIBUTOR FOR DISASSOCIATION OR DISLOCATION WAS REPORTED TO REP (I.E. TRAUMA, PATIENT FACTORS, ETC.).

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8487661 ↗
• InjuryMar 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2019. IN REPORTING A REVISION OF PATIENT'S RIGHT HIP ON (B)(6) 2019, REP WAS MADE AWARE THAT AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON THE PATIENT'S RIGHT HIP. THE BIPOLAR COMPONENT AND FEMORAL HEAD WERE REVISED FOR DEVICES OF THE SAME CATALOG NUMBER (DIFFERENT LOTS). NO REP WAS PRESENT FOR THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 8461356 ↗
• MalfunctionJul 19, 2017Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AFTER IMPACTING THE FEMORAL HEAD, THE SURGEON WENT TO REDUCE THE HIP AND THE INNER C-TAPER CAME OFF THE TRUNNION OF THE STEM. THAT LEFT THE HEAD/BIPOLAR COMPONENT IN THE SOCKET. A NEW HEAD/BIPOLAR COMPONENT WERE USED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6724770 ↗