PINNACLE ALTRX 1221-40-458Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295016601), received between Aug 1, 2017 and Mar 2, 2026 — classified as 59 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT HEAD AND LINER REVISED FOR DISLOCATION. NO DELAYS NO HARM TO PATIENT NO BROKEN INSTRUMENT. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24489991 ↗
• InjuryDec 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DOCTOR COULD NOT GET LINER TO SIT IN THE CUP CORRECTLY. ACTIVITY LEVEL - YES. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23682254 ↗
• MalfunctionSep 9, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT SCREWS WERE NOT LONG ENOUGH. LINER DID NOT SEAT PROPERLY, SO THE DR WANTED ANOTHER LINER. DOE (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008321 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED HIP WASHOUT POLY EXCHANGE/HEAD. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22645859 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CASES WAS A TOTAL HIP THAT WAS BEING REVISED DUE TO SUSPECTED INFECTION. DR. REMOVED THE 58X40MM +4 PINNACLE LINER AND THE 40MM +5 FEMORAL HEAD AND REPLACED THEM AFTER IRRIGATING WITH A 58X40MM +4 LINER AND A 40MM +8.5 HEAD. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22440629 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A HEAD AND LINER EXCHANGE DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21899404 ↗
• InjuryMar 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS TOTAL HIP ARTHROPLASTY ON THE RIGHT HIP AND HAD DISLOCATED SO THE PINNACLE LINER WAS REMOVED AND REPLACED WITH A PINNACLE DUAL MOBILITY LINER. THE METAL 40+5 HEADBALL WAS REMOVED AS WELL. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21631605 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR EXCESSIVE WOUND DRAINAGE. THE CULTURES FOR INFECTION ARE PENDING. THE WOUND WAS OPENED AND IRRIGATED. THE HEAD AND LINER WERE EXCHANGED. THERE WERE NO BROKEN EQUIPMENT, NO DELAYS OR LOOSENING. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 19313906 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH HEAD AND LINER EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17930471 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2023. PATIENT BROUGHT BACK FOR I AND D AS PATIENT HAD SEVERE WOUND HEMATOMA. POLY AND HEAD WERE EXCHANGED. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Hematoma

  MAUDE report 17902098 ↗
• InjurySep 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DEEP INFECTION. DID A WASHOUT AND IMMEDIATE EXCHANGE. DOI: (B)(6) 2023 AND DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17805292 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A DEEP INFECTION. DID A WASHOUT AND IMMEDIATE EXCHANGE. DOI- (B)(6) 2023. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17740899 ↗
• InjuryAug 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD DISLOCATED RIGHT HIP THREE TIMES. SURGEON SWITCHED TO A CONSTRAINED LINER BUT COULD NOT GET THE LOCKING RING TO SEAT SO HE REMOVED IT AND IMPLANTED ANOTHER ONE. THE SECOND LOCKING RING WOULD NOT SEAT EITHER SO THE RING WAS NOT IMPLANTED. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17557104 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO POSSIBLE INFECTION AND SURGEON ELECTED TO DEBRIDE AND CHANGE HEAD, LINER AND HOLE COVER. IT WAS UNKNOWN IF THERE ANY SURGICAL DELAY OR NOT. DOI: (B)(6) 2015, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16618804 ↗
• InjuryDec 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, PATIENT RECEIVED A RIGHT HIP REVISION. ON (B)(6) 2018, PATIENT PRESENTED AT ER WITH PAIN, STIFFNESS, AND INSTABILITY SECONDARY TO A RIGHT HIP DISLOCATION AFTER BENDING OVER AND FEELING A POPPING SENSATION. THE DISLOCATION WAS TREATED WITH A CLOSED REDUCTION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2018, CLINIC NOTE INDICATES THE PATIENT EXPERIENCED A SECOND DISLOCATION OF THE RIGHT HIP AFTER TRYING TO MANUALLY ADDUCT THE RIGHT LEG WHILE SITTING. THE DISLOCATION WAS AGAIN TREATED WITH A CLOSED REDUCTION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THIS DISLOCATION AND TREATMENT IS A CONTINUATION OF THE PREVIOUS DISLOCATION DATED (B)(6), 2018. CLINIC NOTES DATED (B)(6) 2018, (B)(6) 2018, (B)(6) 2018, AND (B)(6) 2018: FOLLOW-UP VISITS S/P DISLOCATION X 2 FOLLOWING RIGHT HIP THA REVISION. RADIOGRAPHS IDENTIFY A WELL-FIXED AND APPROPRIATELY ALIGNED RIGHT THA. THE PATIENT SEES IMPROVEMENT IN PAIN, FUNCTION, AND PARTICIPATION IN ADLS. DOI: (B)(6) 2018. DOE: (B)(6) 2018 AND (B)(6) 2018: DISLOCATION TREATED WITH CLOSED REDUCTION. RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15924108 ↗
• InjuryNov 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO CHRONICALLY DISLOCATING. REMOVED 58 +4 N ALTRX LINER AND REPLACED WITH A 58 +4 10 CONSTRAINED LINER. NO ISSUES WITH PRODUCTS. NO DAMAGE REPORTED. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15793622 ↗
• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEPTIC HIP APPROXIMATELY 12 YRS POST PRIMARY IMPLANTATION. I&D W/HEAD LINER EXCHANGE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15657394 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD I&D, POLY EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 15380365 ↗
• InjuryJun 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2022; DOR: (B)(6) 2022; RIGHT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 14685476 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY : DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR MASS IN RT POSTERIOR THIGH, HAMSTRING REGION EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT (CUP): (B)(6) 2003, DATE OF IMPLANT: (B)(6) 2012, DATE OF EVENT: (B)(6) 2021, (RIGHT HIP). TREATMENT: DIAGNOSTIC MRI.

  Patient problems: Cyst(s); Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 12512569 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT HIP.

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

  MAUDE report 12415515 ↗
• InjuryAug 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED AND THUS REVISION WAS SCHEDULED. DOI: UNKNOWN, DOR: UNKNOWN. UNKNOWN SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 12361183 ↗
• InjuryAug 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR DISLOCATION LEFT THA - INITIAL EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2007; DATE OF REVISION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2021; (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION. DEPUY COMPONENTS: CATALOG ID: 550536, LOT ID: 2275276, DESCRIPTION: SROM SLEEVE PROXIMAL TITANIUM 20F LG.

  Patient problems: Joint Dislocation

  MAUDE report 12282994 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS UNSURE OF THE PATIENTS ORIGINAL SURGERY DATE, WHO PERFORMED THE SURGERY, OR WHERE IT WAS DONE. PATIENT WAS SUFFERING FROM BURSITIS AND THE CASE WAS BOARDED AS A BURSECTOMY WITH POSSIBLE HEAD AND LINER EXCHANGE. SURGEON INFORMED THE PATIENT THAT IF HE WENT INTO THE HIP CAPSULE HE WOULD CHANGE THE HEAD AND LINER. ONCE GETTING INTO THE HIP, HE FELT THE PATIENT WOULD BENEFIT FROM GETTING THE HEAD AND LINER EXCHANGED. A 40MM +9 HEAD AND 40X58 +4 NEUTRAL LINER WERE REMOVED. THE SURGEON OPTED TO IMPLANT A 36X58 +4 NEUTRAL LINER BECAUSE HE WANTED TO HAVE A CERAMIC HEAD AS AN OPTION. EVEN THOUGH HE WAS TOLD IT WAS OFF LABEL, HE FELT THE FEMORAL NECK WAS IN GOOD ENOUGH CONDITION TO RECEIVE A 36 CERAMIC. A TRAIL REDUCTION WAS PERFORMED WITH A 36MM +9. IT WAS FOUND TO BE STABLE, SO THE REAL HEAD WAS OPENED AND IMPLANTED. THE HIP WAS REDUCED AND THE CLOSING PROCESS BEGAN. DOI: UNKNOWN - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Inflammation

  MAUDE report 12173120 ↗
• InjuryJun 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY AND THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12041259 ↗