X3 1236-2-858Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540639028), received between Jun 30, 2017 and Jul 28, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryJul 28, 2025Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  AS REPORTED: "REVISION OF LEFT TOTAL HIP DONE TODAY. THIS PATIENT PRESENTED WITH A PERIPROSTHETIC FRACTURE OF HIS RIGHT HIP WHICH WAS COMPETITOR TOTAL HIP. ORIGINALLY THE LEFT HIP WAS NOT A PROBLEM. THE RIGHT HIP WAS REVISED ON (B)(6) 2025 TO ADDRESS THE FRACTURE USING COMPETITOR PRODUCTS. AFTER THAT SURGERY IT WAS DISCOVERED THAT THE LEFT HIP HAD DISLOCATED. THE LEFT HIP WAS REDUCED AND TRANSFERRED FROM TRAUMA SERVICE TO JOINT REPLACEMENT SERVICE. IT WAS DISCOVERED THAT THE 28MM HEAD HAD DISASSOCIATED FROM THE MDM POLY LINER. IT IS THOUGHT THAT THIS DISASSOCIATION OCCURS WHEN THE HIP WAS REDUCED. THE REVISION TODAY WAS TO ADDRESS THE INSTABILITY OF THE LEFT HIP. MDM IMPLANTS WERE REMOVED AND A CONSTRAINED LINER WAS PLACED. IT WAS ALSO DECIDED TO GO FROM A +4 NECK LENGTH TO A +8 TO ADDRESS LIMB LENGTH DISCREPANCY. NO FURTHER INFORMATION AVAILABLE FROM SURGEON OR HOSPITAL." REP CONFIRMED THAT INTRA-OPERATIVELY, THE POLY WAS FOUND FLOATING IN THE JOINT.

  Patient problems: Joint Laxity

  MAUDE report 22638123 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY LEFT THA OUT OF CORS SCOPE. ON (B)(6) 2022 THE PATIENT HAS A PERIPROSTHETIC JOINT INFECTION AND IS ENTERED INTO CORS WITH A PROXIMAL FEMORAL REPLACEMENT. THE PATIENT DEVELOPED AGAIN INFECTION OF THE LEFT HIP AND UNDERWENT REVISION FOR PJI WITH ONLY THE MDM & HEAD COMPONENTS EXCHANGED ON (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 15974370 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. ALL REPORTED DEVICES WERE REVISED. PATIENT HAD PREVIOUSLY HAD A POLY SWAP THE WEEK BEFORE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11770794 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. A POLY SWAP WAS DONE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11733680 ↗
• InjuryDec 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED "SURGEON DID A HEAD EXCHANGE DUE TO POSSIBLE INFECTION. X-RAY, ORIGINAL [USAGE] SHEET, REVISION. [USAGE] SHEET ALL ATTACHED. NO OTHER INFORMATION AVAILABLE PER HOSPITAL POLICY." THE FEMORAL HEAD AND ADM/ MDM INSERT WERE REVISED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9484893 ↗
• InjuryAug 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PATIENT IS A SUBJECT IN STRYKER ADM X3 ACETABULAR SYSTEM STUDY. AT THE SUBJECT'S 6-YEAR FOLLOW-UP THE SUBJECT REPORTED HE WAS UNSATISFIED WITH THE RESULTS OF HIS HIP REPLACEMENT DUE TO SORENESS IN HIP WITH EXTENDED WALKING.

  Patient problems: Pain

  MAUDE report 8902284 ↗
• InjuryJun 30, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SURGEON REVISED A THA PATIENT DUE TO DISLOCATION. WITH CONTINUED PAIN THE SURGEON HAD A CT SCAN DONE WHICH SHOWED THAT THE FEMORAL HEAD PULLED OUT OF THE MDM OUTER BALL. SURGEON REVISED THE PATIENT TO A COBALT CHROME HEAD AND NEW MDM OUTER BALL.

  Patient problems: Injury; Pain

  MAUDE report 6681004 ↗