PINNACLE ALTRX 1221-32-148Recalls & reported problems

Summary

The FDA's MAUDE database contains 180 adverse event reports that list this exact device (DI 10603295016151), received between Jun 23, 2017 and Sep 28, 2026 — classified as 176 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (104 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 25 most recent of 180 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Fracture; Noise, Audible

  It was reported that the patient came into clinic reporting a squeak sound, images were taken. The patient was revised due to hip liner breakage. Surgeon did a head and liner exchange. The reported outcome was that the revision went well and the patient returned home.

  Patient problems: Insufficient Information

  MAUDE report 50915274 ↗
• InjurySep 18, 2026Device Dislodged or Dislocated

  It was reported that recurrent left hip dislocations.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Unknown.

  Patient problems: Joint Dislocation

  MAUDE report 50817253 ↗
• InjuryAug 31, 2026Device Dislodged or Dislocated

  It was reported that the patient was revised due to hip dislocation. The doctor removed liner and head and replaced with a constrained liner and new head for appropriate length. DOI: (b)(6), 2026.DOR: (b)(6) 2026.Affected side: Right Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50532057 ↗
• InjuryAug 7, 2026Appropriate Device Problem Term/Code Not Available

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysis.Reason for revision: Revision due to infection. The bore of the ceramic head shows corrosion at revision. he non-articular surface of the polyethylene acetabular liner shows minor yellowing and 3 screw hole defects.

  Patient problems: Unspecified Infection

  MAUDE report 50177982 ↗
• InjuryJul 30, 2026Device Dislodged or Dislocated

  It was reported that the patient underwent total left hip arthroplasty on (b)(6)2022. Patient subsequently experienced hip pain after feeling a "pop". An X-ray revealed decentralization of the modular head relative to the acetabular components (cup/liner). Patient underwent hip revision surgery on (b)(6)2026, during which the surgeon opted to use Competitor's acetabular implants and a modular head.

  Patient problems: Pain

  MAUDE report 50084266 ↗
• InjuryApr 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO UNSTABLE HIP- DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25001673 ↗
• MalfunctionApr 20, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POLY WEAR. DOI: (B)(6) 2020. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926769 ↗
• InjuryApr 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CASE WAS REVISED DUE TO DISLOCATION. THE DOCTOR REMOVED THE 32X48+4 10D LINER AND COULD NOT PLACE A NEW TRIAL DUE TO BONE COVERING THE THREADS. DOCTOR IMPLANTED A 32X48 +4 TO TRIAL WITH, THEN EXTRACTED IT AND IMPLANTED A 32+4 10D WITH A 32+5 TS CERAMIC HEAD. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24790219 ↗
• InjuryMar 31, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLLOWING A TOTAL HIP REPLACEMENT ON THE LEFT SIDE, A SUBSEQUENT PROCEDURE IS REQUIRED TO EXCHANGE THE MATERIAL DUE TO POSSIBLE DAMAGE TO THE IMPLANTED PRODUCT, AS INDICATED BY RADIOGRAPHIC EVIDENCE OF IMPLANT DISPLACEMENT. THE PATIENT EXPERIENCED DAMAGE OR LOSS AND REQUIRED A CORRECTIVE SURGICAL INTERVENTION BUT DID NOT REQUIRE PROLONGED HOSPITALIZATION AND IS CURRENTLY IN RECOVERY.

  Patient problems: Insufficient Information

  MAUDE report 24741961 ↗
• InjuryMar 13, 2026Device Dislodged or Dislocated; Naturally Worn

  RECEIVED ADDITIONAL INFORMATION: AFTER INVESTIGATION, THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN THE HOSPITAL DUE TO "HIP ARTHRITIS" ON (B)(6) 2023. THE SURGEON IMPLANTED (B)(6) DURING THE SURGERY, AND THE HOSPITAL REPORTED THAT THE SURGICAL PROCESS AND POSTOPERATIVE REHABILITATION WERE SMOOTH. IN EARLY 2026 (SPECIFIC TIME UNKNOWN), THE PATIENT WAS UNABLE TO WALK DUE TO LOWER LIMB PAIN AND WENT TO THE HOSPITAL FOR TREATMENT. AFTER CT AND X-RAY EXAMINATIONS, IT WAS FOUND THAT THE LINER WAS SIGNIFICANTLY WORN, RESULTING IN FEMORAL HEAD DECENTRATION. THEREFORE, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 TO REMOVE THE WORN LINER. THE PATIENT IS CURRENTLY IN A STABLE CONDITION AND NO SUBSEQUENT ADVERSE EVENT REPORTS HAVE BEEN RECEIVED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 24592937 ↗
• InjuryFeb 19, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NOISY HIP, AFTER X-RAYS IT WAS NOTED THAT THE POLYETHYLENE LINER HAD MOVED AND THE CERAMIC HEAD WAS WEARING ON THE METAL CUP.

  Patient problems: Insufficient Information

  MAUDE report 24391154 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION DUE TO IMPLANT. SWAPPING HEAD AND LINER. DOI- (B)(6) 2025, DOR- (B)(6) 2026, AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24190797 ↗
• InjuryNov 4, 2025Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS THE REASON FOR THE REVISION WAS DUE TO RECURRENT DISLOCATION. THE FEMORAL HEAD SHOWED MINOR METAL TRANSFER. THE LINER SHOW MINOR YELLOWING.

  Patient problems: Joint Dislocation

  MAUDE report 23471127 ↗
• InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO HIP DISLOCATION AND THE DR. DECIDED TO REVISE TO A CONSTRAINED LINER. IT WAS NOT A PROBLEM WITH THE IMPLANTS OR THE VERSION OF CUP OR STEM. HE WAS GOING TO GO TO A LONGER HEAD TO ADD LENGTH FOR STABILITY BUT DECIDED TO DO THE CONSTRAINED LINER BECAUSE OF THE PATIENT HEALTH. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23294318 ↗
• InjurySep 3, 2025Fracture; Fracture

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY. DURING INVESTIGATION OF THE RETURNED PRODUCT IT WAS NOTED THE REVISION WAS LIKELY DUE TO A FRACTURED LINER THAT HAS DISASSOCIATED FROM THE CUP.

  Patient problems: Insufficient Information

  MAUDE report 22952841 ↗
• InjuryAug 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT PRESENTED WITH A POSSIBLE DISLOCATED OR BROKEN POLY ACETABULAR LINER. PATIENT HAS A HIGH BMI AND WAS GETTING VERY CLOSE TO DISLOCATING ON THE EDGE OF THE POLY LINER WHICH EVENTUALLY LEVERED THE POLY LINER TO CAUSE IT TO DISASSOCIATE FROM THE CUP. THERE WAS LOOSENING OF ACETABULAR POLY LINER AT UNKNOWN INTERFACE. UNKNOWN CEMENT WAS USED. SURGEON REMOVED HEAD AND POLY, PROCEEDED TO TRIAL A DUAL MOBILITY CONSTRUCT WHICH WAS VERY STABLE. FINAL DUAL MOBILITY CONSTRUCT WAS IMPLANTED. ALL AVAILABLE INFORMATION HAS BEEN FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22926024 ↗
• InjuryJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED DUE TO POOR CUP PLACEMENT AND UNDERWENT THE CUP AND LINER EXTRACTION. THERE WAS NO SPECIFIC ALLEGATION AGAINST THE LINER AND CUP. PATIENT WAS REVISED TO COMPETITOR'S CUP. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22414725 ↗
• InjuryJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO HIP DISLOCATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22366454 ↗
• InjuryJun 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POSTERIOR DISLOCATION, SURGEON REPLACED THE HEAD AND LINER. ALL IMPLANTS WERE REMOVED FROM SURGERY, THE EXPLANTATION TOOK APPROXIMATELY 15 MINUETS AND THERE WAS NO HARM DONE TO THE PATIENT. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22299383 ↗
• InjuryJun 4, 2025Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SUCCESSFUL LEFT TOTAL HIP ARTHROPLASTY USING DEPUY SYNTHES IMPLANTS. IN (B)(6) 2025, THE PATIENT HAD A FOLLOW-UP APPOINTMENT AND STATED A FEW DAYS PRIOR, THE PATIENT NOTICED A SQUEAKING SOUND FOLLOWING BENDING AND INCREASED FLEXION OF THE LEFT HIP. THE PATIENT ALSO HAS PAIN WHEN LOADING THE JOINT. THE PATIENT LIMPS AND HAS AN ANTALGIC GAIT PATTERN. X-RAYS SHOW THE INSERT HAS WEAR ON THE LEFT SIDE CAUSING SUPERIOR MIGRATION OF THE HEAD. REVISION WAS PERFORMED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain

  MAUDE report 22141536 ↗
• InjuryJun 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO MULTIPLE DISLOCATIONS. DOI: (B)(6) 2019, DOR: UNKNOWN, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22140841 ↗
• InjuryMay 5, 2025Fracture; Naturally Worn; Noise, Audible; Fracture; Naturally Worn; Noise, Audible

  ON (B)(6) 2022, THE PATIENT HAD LEFT TOTAL HIP ARTHROPLASTY. DEPUY COMPONENTS WERE IMPLANTED., INCLUDING 2 SCREWS. (B)(6) 2024 PATIENT REPORTS AUDIBLE SQUEAKING IN HIP, AND PAIN AT NIGHT AND SLIGHT LEG LENGTH DISCREPANCY. (B)(6) 2025 PATIENT HAD A LEFT HIP REVISION TO ADDRESS FAILED LEFT TOTAL HIP. DURING THE PROCEDURE THE SURGEON REPORTED THAT THERE WAS A NOTABLE QUANTITY OF FLUID IN HIP, THE FEMORAL HEAD WAS SIGNIFICANTLY WORN, AND THE POLYETHYLENE HEAD (LINER) WAS EXTRACTED IN NUMEROUS DIFFERENT PIECES AND APPEARED WORN. THERE WAS SYNOVITIS WITH METALLIC DEBRIS.

  Patient problems: Cellulitis; Pain; Physical Asymmetry; Swelling/ Edema; Synovitis

  MAUDE report 21962565 ↗
• InjuryMar 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THE INSERT HAS WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630897 ↗
• InjuryMar 13, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT SINCE THE END OF (B)(6) 2024, THE PATIENT HAS NOTICED CREAKING IN THE OPERATED HIP IN THE FLEXION-EXTENSION POSITION. DURING REVISION SURGERY, THE INSERT WAS REPLACED BECAUSE IT WAS WORN OUT / FRAYED. THERE WAS NO SURGICAL DELAY; NO PATIENT HARM.

  Patient problems: Foreign Body Reaction; Insufficient Information; Pain

  MAUDE report 21596680 ↗
• InjuryMar 11, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER WAS BROKEN DUE TO CUP POSITION AND IMPLANT IMPINGEMENT. THERE WAS LINER LOOSENING AT NON-CEMENTED INTERFACE. ALL PIECES WERE RETRIEVED. DOI: UNKNOWN AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21577529 ↗