NA 1014-67-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295001256), received between Sep 1, 2017 and Sep 24, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PC IS TO CAPTURE THE MEDICAL RECORD FROM (B)(6) 2021 NOTE THAT THE PATIENT HAS DISLOCATED 3 TIMES AND HAS INSTABILITY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 12525388 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL HIP DUE TO WORN POLY. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 12406682 ↗
• InjuryAug 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION AND MEDICAL RECORDS RECEIVED INDICATED THAT ON (B)(6) 2020, THE PATIENT HAD A REVISION LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS FAILED LEFT HIP. THE POLY LINER WAS NOTED TO HAVE BEEN COMPLETELY WORN THROUGH. THE PATIENT WAS NOTED TO HAVE INCREASING DISCOMFORT, PAIN, DECREASED RANGE OF MOTION, AND PREOPERATIVE RADIOGRAPHS REPORTEDLY SHOWED EVIDENCE OF MIGRATION. DEPUY COMPONENTS WERE NOTED TO HAVE BEEN USED DURING THIS PROCEDURE. DURING THE PROCEDURE THE SURGEON OBSERVED THAT THE POLY LINER HAD BEEN COMPLETELY WORN THROUGH. THERE WAS SLIGHT DAMAGE TO THE METAL SHELL, BUT IT WAS RETAINED. THERE BLACK TISSUE DUE TO TITANIUM DEBRIS. THE FEMORAL STEM WAS WELL FIXED AND RETAINED. THE TROCHANTERIC CLAMP WAS REMOVED. BONE LOSS AND OSTEOLYSIS WERE ALSO NOTED. MEDICAL RECORDS FROM 06/22/2021 NOTE THAT THE PATIENT IS 6 MONTHS POST REVISION, DISLOCATED HIP AND HAD TO HAVE IT REDUCED. MEDICAL RECORD FROM 08/02/2021 NOTE THAT THE PATIENT HAS DISLOCATED 3 TIMES AND HAS INSTABILITY.

  Patient problems: Joint Dislocation

  MAUDE report 12341912 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 11275884 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION, CHANGED HEAD MM BECAUSE OF POLY SWAP. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11011984 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WAS REVISED BY THE SURGEON FOR POLY WEAR IN A STRYKER VITALOCK CUP AND EXCHANGE THE HIP BALL ON A AMLSTEM. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP. UPDATE AD 24 SEP 2019; ADDITIONAL INFORMATION RECEIVED: AS PER THE SALES REP, THE PATIENT WAS EXPERIENCING SOME HIP INSTABILITY."

  Patient problems: No Code Available

  MAUDE report 9186639 ↗
• InjurySep 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED AND BROUGHT TO OPERATION ROOM. LINER AND HEAD REMOVED. SEVERE LYSIS CLEANED AWAY AND BONE GRAFTED IN BOTH PELVIS AND TROCHANTER. A CONSTRAINED LINER WAS THEN CEMENTED INTO THE EXISTING WELL FIXED SHELL. HEAD HAD BEEN IMPLANTED AT 329915 ON (B)(6), AND THE LINER THAT WAS REMOVED WAS IMPLANTED ON (B)(6) AT 160490. DOI: (B)(6) 2019 (HEAD); (B)(6) 2019 (LINER); DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available; Osteolysis

  MAUDE report 9084326 ↗
• InjuryMar 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8447536 ↗
• InjuryFeb 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO CHRONIC DISLOCATION, PUT IN A CONSTRAINED LINER.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8342939 ↗
• InjuryFeb 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8315381 ↗
• InjurySep 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAINFUL HIP.

  Patient problems: Pain

  MAUDE report 6837804 ↗