PINNACLE ALTRX 1221-40-462Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295393535), received between Jun 22, 2017 and Aug 10, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Naturally Worn; Appropriate 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 malpositioned cup and pain. At revision non-articular surface of the polyethylene acetabular liner shows 1 screw hole defect.

  Patient problems: Pain

  MAUDE report 50191167 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED HIP, WASHOUT POLY AND HEAD EXCHANGE. DOI-UNKNOWN. DOR-UNKNOWN. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25330994 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUFFERED A GLUTEUS MAXIMUS TEAR AND NEEDED A REPAIR. IN THE PROCESS OF REPAIRING THE TEAR, THE SURGEON NEEDED TO DISLOCATE THE HIP PROSTHESIS AND CHOSE TO IMPLANT A FRESH DM FOR BETTER STABILITY. THE END. NO ISSUE TO IMPLANTS, JUST A SWAP OUT. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 23497423 ↗
• InjuryJun 17, 2025Adverse 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 PAIN. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 22229402 ↗
• InjuryNov 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTES RECEIVED. ON (B)(6) 2023 MEDICAL RECORDS NOTE THE PATIENT HAD A FOLLOW-UP FOR STATUS POST BIKE ACCIDENT. THE PATIENT DISLOCATED THE RIGHT HIP, WHICH WAS REDUCED. PATIENT HAS A QUITE A BIT OF PAIN ALONG MEDICAL SIDE OF KNEE. PATIENT IS STATUS POST RIGHT HIP, 7 YEARS PRIOR, AND STATUS POST RIGHT KNEE ARTHROPLASTY, 3 YEARS PRIOR. RADIOGRAPHS NOTE A WELL PLACED RIGHT SROM PROSTHETIC, WHICH IS STABLE. THERE IS MCL RUPTURE AT LEAST SECOND-DEGREE. THE PLAN IS FOR THE PATIENT TO USE A KNEE BRACE. ON (B)(6) 2023 MEDICAL RECORDS NOTE, THE PATIENT HAD RIGHT KNEE MEDICAL COLLATERAL LIGAMENT SPRAIN AND REVIEW OF PREVIOUS RIGHT HIP DISLOCATION. IMPRESSION, STATUS POST RIGHT HIP DISLOCATION, DOING WELL, AND STATUS POST RIGHT KNEE MCL SPRAIN, STATUS POST KNEE REPLACEMENT, DOING WELL. (B)(4) IS FOR RIGHT KNEE. AFTER REVIEW OF THE CLINICAL DATA BASE, THE REPORTED KNEE PAIN AND MCL SPRAIN ARE NOTED TO BE NOT DEVICE OR PROCEDURE RELATED AS PATIENT WAS INVOLVED IN A BIKE ACCIDENT.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 18149056 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS REMOVED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18031322 ↗
• InjuryJun 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17182298 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED HIP. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16991408 ↗
• InjuryApr 5, 2022Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS A RECURRENT DISLOCATOR. THE SURGEON REVISED THE ZIMMER STEM AND CHANGED THE LINER IN OUR ACETABULUM. THE PINNACLE CUP IS WELL FIXED AND RETAINED. THE PATIENT IS STABLE NOW. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14014706 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Pain

  MAUDE report 12977614 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: IT WAS REPORTED THAT THE COMPONENTS WERE EXCHANGED FOR INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 12440430 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED LEFT INFECTED TOTAL HIP ARTHROPLASTY OPERATIVE NOTES INDICATED SCARRING AND SMALL POSTERIOR SUPERIOR DEFECT. PATHOLOGY REPROT REPORTED OF PATCHY ACUTE AND CHRONIC INFLAMMATION. DOI: (B)(6) 2010 (CUP, STEM); DOI: (B)(6) 2016 (LINER & HEAD); DOR: (B)(6) 2017 LEFT HIP.

  Patient problems: Adhesion(s); Inflammation; No Code Available; Unspecified Infection

  MAUDE report 9903555 ↗
• InjuryOct 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED. CONSTRAINED LINER AND SHORTER PROXIMAL BODY IMPLANTED. DOI: UNKNOWN; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9185106 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS HEMATOMA POSTOPERATIVELY. WASHED OUT WITH COMPONENT EXCHANGE. DOI: (B)(6) 2019. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: Hematoma; No Code Available; Unspecified Infection

  MAUDE report 8983329 ↗
• InjuryAug 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE. DOI: (B)(6) 2018; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8875846 ↗
• InjuryAug 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION. DOI: (B)(6) 2018 - DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8875336 ↗
• InjuryJun 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT HIP DISLOCATION, INITIAL ANTERIOR DISLOCATION OF REVISION THAT: EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DOI: (B)(6) 2009. DOR: (B)(6) 2019 (HEAD AND LINER). DOE: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8696596 ↗
• InjuryMar 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION. DOI: (B)(6) 2016 - DOR: (B)(6) 2018, (RIGHT HIP). THIS PC IS FOR THE SECOND REVISION OF THE RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8431963 ↗
• InjuryFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. PERFORMED A WASH OUT AND POLY AND HEAD SWAP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8302446 ↗
• InjuryJul 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7706030 ↗
• InjuryJun 26, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES THAT THE PATIENT RECEIVED A TOTAL HIP ARTHROPLASTY IN (B)(6) 2018. THE PATIENT ARRIVED AT THE EMERGENCY ROOM AND STATED THE HIP HAD BEEN DISLOCATED FOR APPROXIMATELY 2 WEEKS. CLOSED REDUCTION WAS UNSUCCESSFUL SO THE PATIENT'S HIP WAS OPENED AND REVISED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7637159 ↗
• InjuryFeb 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGES PAIN, FATIGUE, MUSCLE WEAKNESS, DIFFICULTY WALKING AND STANDING. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. REVISION NOTE STATES, THERE WAS EVIDENCE OF PREVIOUS POSTERIOR DISLOCATION WITH A LARGE AMOUNT OF HEMARTHROSIS IN AND AROUND THE JOINT. ASSESSMENT OF THE ACETABULUM REVEALED THAT INDEED THE POSITIONING OF THE CUP WAS SLIGHTLY UNDER ANTEVERTED, ESPECIALLY GIVEN HIS HISTORY OF BACK FUSION. DOI: CUP (B)(6) 2010. DOI: LINER AND HEAD (B)(6) 2017 : DOR: (B)(6); 2017 (LEFT HIP RE-REVISION).

  Patient problems: Fatigue; Joint Dislocation; Pain; Weakness

  MAUDE report 7269459 ↗
• InjuryNov 3, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTED THA WITH DRAINING WOUND. IRRIGATION AND DEBRIDEMENT WITH EXCHANGE OF COMPONENTS DONE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6998805 ↗
• InjuryJun 22, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: No Information

  MAUDE report 6660562 ↗