PINNACLE ALTRX 1221-28-146Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295015994), received between Oct 2, 2018 and May 15, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD UNSTABLE HIP. DOI: (B)(6) 2020. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25190671 ↗
• InjuryNov 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PATIENT HAS A SROM PINNACLE CONSTRUCT IMPLANTED SOMETIME AGO. THE ORIGINAL DATE OF SURGERY IS UNKNOWN. THE PATIENT WAS DOING WELL YEARS AFTER THE SURGERY UNTIL RECENTLY WHERE PATIENT BECAME UNSTABLE AND DISLOCATED. SEVERAL CLOSED REDUCTIONS WERE DONE OVER THE PAST YEAR. AS THEY BECAME MORE FREQUENT, THE DECISION WAS MADE TO REVISE THE PATIENTS CONSTRUCT. DOCTOR EXPLANTED THE PATIENTS PINNACLE ACETABULAR CUP, LINER, AND SROM FEMORAL HIP BALL. THE SROM STEM AND SLEEVE WERE LEFT IN SITU. DOCTOR STATED THAT THE ACETABULAR CUP ABDUCTION ANGLE WAS TOO VERTICAL WHICH CONTRIBUTED TO THE DISLOCATION ISSUE. A NEW ACETABULAR CUP AND FEMORAL HIP BALL WERE IMPLANTED PROVIDING SATISFACTORY STABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23606689 ↗
• InjuryApr 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO POOR CUP POSITION LEADING TO DISLOCATION. SURGEON IMPLANTED A NEW CUP, LINER, AND HEAD. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED AREA: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21754816 ↗
• InjuryAug 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TEN DEGREE LINER CRACKED AND FELL APART. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19982669 ↗
• InjuryNov 1, 2023Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO A DEFORMED LINER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18047438 ↗
• InjuryAug 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON PUT IN NEW HEAD & LINER. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618504 ↗
• InjuryJun 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HIP INSTABILITY WITH RECURRENT DISLOCATION.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17152642 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17097615 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LACK OF MOTION. SURGEON EXCHANGED POLY AND HEAD. PUT BACK IN SAME POLY AND WENT UP A HEAD SIZE. NO INSTRUMENTS BROKEN DURING SURGERY. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Loss of Range of Motion

  MAUDE report 16920805 ↗
• InjuryMay 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. THE CUP WAS EXPLANTED AND A MULTI HOLE CUP W A 10° LINER AND A LONGER HEAD WAS IMPLANTED. THE HEAD SIZE WAS INCREASED FROM 28 TO 40. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16878651 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16151923 ↗
• InjuryOct 4, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION WAS DONE DUE TO POLY BREAKAGE AND PAINFUL HIP. LOCKING MECHANISM FAILED AND POLY WAS DISENGAGED AND HEAD WAS RUBBING ON METAL CUP RIM. DOI: 2014. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 15537006 ↗
• InjuryAug 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON DID A THA IN THIS PATIENT APPROXIMATELY A YEAR AND A HALF AGO ACCORDING TO THE DOCTOR. THIS PATIENT DID FINE INITIALLY BUT HAS DISLOCATED SEVERAL TIMES OVER THE LAST FEW MONTHS. THE SURGEON AND THE PATIENT DECIDED TO DO A REVISION ON THE HIP TO ACHIEVE GREATER STABILITY. THE 46MM ACETABULAR CUP , 28MM + 5 HIP BALL, 25MM SCREW, 46 ALTRX LINER WERE EXPLANTED AND REPLACED WITH A 50MM ACETABULAR CUP WHERE SURGEON HAD A CONSTRAINED LINER OPTION TO PROVIDE OPTIMAL STABILITY. I DO NOT HAVE ADDITIONAL INFORMATION TO SHARE AT THIS TIME. DOI: APPROXIMATELY A YEAR AND A HALF AGO. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15241209 ↗
• InjuryJul 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATION. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14957083 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE STEM WAS IMPINGING ON THE LINER. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information; Unspecified Musculoskeletal problem

  MAUDE report 13590402 ↗
• InjuryJun 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP HAD DISLOCATED AND REQUIRED AN EXCHANGE OF THE FEMORAL HEAD. THE LINER WAS NOT REVISED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11917111 ↗
• InjuryOct 27, 2020Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT HEARD A POP AND THEN HAD HIP PAIN. LINER DISASSOCIATED FROM THE CUP. DURING THE REVISION IT WAS NOTED THAT THE LIP OF THE LINER HAD ECCENTRIC WEAR INDICATIVE OF GRUNION IMPINGEMENT. DOI: (B)(6) 2018. DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10740670 ↗
• InjurySep 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  28 X 46 PLUS 4 10 DEGREE LINER DISASSOCIATED.

  Patient problems: No Code Available

  MAUDE report 10508711 ↗
• InjuryFeb 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION OF THE LEFT HIP. SURGEON EXPLANTED PINNACLE CUP, LINER AND STEM REVISING WITH COMPETITIVE MDM. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9727689 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ARRIVED IN ER WITH PAIN IN GROIN AND FEELING SICK. HIP IS FOUND TO BE INFECTED. I&D OF HIP IS SCHEDULED. WHILE IN PREOP, SURGEON QUESTION ABOUT ANT KNEE PAIN AND THE PATIENT STATES IT BEGAN HURTING THIS MORNING. PRIOR TO STARTING HIP, AN ASPIRATION IS PERFORMED ON KNEE AND PUSS WAS REMOVED. I&D OF HIP AND KNEE WE PERFORMED WITH COMPONENT EXCHANGE. KNEE WAS PUT IN ON DATE ABOVE. HIP WAS PERFORMED ON (B)(6) 2019. LPS DISTAL FEMUR NOT REMOVED, BUT PIN AND BUMPER WERE REPLACED. PT HAS SEVERE RA. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9521333 ↗
• InjuryNov 18, 2019Fracture; Naturally Worn; Fracture; Naturally Worn

  DR. SAW ONE OF HIS PATIENT AT A 5 YEAR FOLLOW UP. UPON TAKING X-RAYS HE NOTICED WHATS BELIEVED TO BE SIGNIFICANT POLY WEAR TO THE ALTRX LINER IMPLANTED. IMPLANTS: 46MM PINNACLE CUP, 28ID/46OD +4 10D LINER, 28MM +6 (UNCLEAR IF METAL OR CERAMIC WAS USED BASED ON OP REPORT THAT IS WHY IT IS NOT ENTERED IN THE IMPACTED PRODUCT LISTING BELOW), AND A 36STND 9X14 SROM FEMORAL STEM. DR. DID THE CONTRALATERAL SIDE IN THE FOLLOWING YEAR ALSO USING THE SROM STEM. THERE DOES NOT APPEAR TO BE WEAR SEEN ON THAT SIDE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9336519 ↗
• InjuryJul 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION WITH OPEN REDUCTION AND ELEVATED METAL IONS AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATING RIGHT TOTAL HIP ARTHROPLASTY. DOI: (B)(6) 2013; DOR: (B)(6) 2014; (RIGHT HIP) 2ND REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8799362 ↗
• InjuryJul 9, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  PINNACLE LEGAL CLAIM AND MEDICAL RECORDS RECEIVED. IT WAS REPORTED THAT THE PATIENT'S POLY LINER WAS DEFECTIVE. AFTER REVIEW OF MEDICAL RECORDS, THERE WAS NO REVISION REPORTED. NO KNOWN PATIENT CONSEQUENCE. DOI: (B)(6) 2015, DOR: (B)(6) 2017, (RIGHT HIP).

  Patient problems: Anxiety; Depression; Foreign Body Reaction; Injury; Joint Dislocation; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 8773387 ↗
• InjuryJul 9, 2019Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. LITIGATION ALLEGES DISLOCATION. DURING THE PROCEDURE THE SURGEON FOUND THAT THE DISLOCATION WAS EVIDENT AND THERE WAS A FAILURE OF THE LOCKING MECHANISM OF THE LINER. PATIENT ALSO SUFFERED PAIN, LACK OF MOBILITY AND EMOTIONAL DISTRESS. UPDATED PATIENT IDENTIFIER. DOI: (B)(6) 2017 - DOR: (B)(6) 2017, (RIGHT HIP).

  Patient problems: Joint Dislocation; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 8772870 ↗
• InjuryApr 24, 2019Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS LEFT HIP PAIN: 3 WEEKS POST-OP,1 YEAR OFFICE FOLLOW-UP.LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8545644 ↗