PINNACLE ALTRX 1221-40-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295393368), received between Jun 11, 2018 and Apr 20, 2026 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO HIP PAIN COMPLAINT. DOI- (B)(6) 2021. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Pain

  MAUDE report 24927133 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6) HOSPITAL AND (B)(6), AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER (B)(4), 70-YEAR-OLD MALE. PATIENT EXPERIENCED A POST OPERATIVE SUPERFICIAL WOUND INFECTION REQUIRING ANTIBIOTICS AND WOUND VAC. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2024.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 23526149 ↗
• InjuryOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT¿S HIP WAS DISLOCATED AND CONCERNS OF INFECTION. SURGEON REPLACED CUP, LINER AND HEAD. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 23357361 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN INFECTED HIP. THE IMPLANTS WERE REMOVED TO PUT IN A TEMPORARY SPACER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23348139 ↗
• MalfunctionJul 18, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT LINER WOULD NOT SEAT IN CUP. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542416 ↗
• InjuryJun 18, 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 INFECTION OF HIP. POLY AND HEAD WERE EXCHANGED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22284215 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REPLACEMENT SURGERY ON (B)(6) 2024. SUBSEQUENTLY, THE HIP BEGAN TO DRAIN FLUID. SURGERY PERFORMED POLY AND HEAD AND USED WASHOUT AND IRRIGATION AND DEBRIDEMENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 21026435 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT REQUIRED A WASHOUT. AND REPLACEMENT OF LINER AND FEMORAL HEAD. THERE WAS AN INFECTION IN JOINT GAP POST SURGERY. ONLY THE LINER AND POLY WERE REPLACED. NO REQUIREMENT FOR REVISION OF THE CUP.

  Patient problems: Unspecified Infection

  MAUDE report 20588980 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INFECTION, FRETTING INSIDE THE FEMORAL HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 19168437 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A RIGHT HIP NON MOM THA HIP AND WAS REVISED TO FIX THE HIP DISCREPANCY. DOI: (B)(6) 2020; DOR: (B)(6) 2022 ; RIGHT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 19165878 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INFECTION & PAIN.

  Patient problems: Pain

  MAUDE report 18961049 ↗
• InjuryJan 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT EXPERIENCED A "POP" IN THE HOSPITAL IMMEDIATELY AFTER SURGERY. THEN FELT ANOTHER CLICK AND EXPERIENCED PAIN. INTRA OP DURING THE REVISION CONFIRMED THE POLY LINER WAS DISLODGED. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18483382 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HO REMOVAL AND SCIATIC NEUROLYSIS. HEAD AND LINER WAS EXCHANGED. DOI: (B)(6), 2022 DOR: (B)(6), 2023 AFFECTED SIDE: LEFT HIP

  Patient problems: Extraskeletal ossification; Nerve Damage

  MAUDE report 17971212 ↗
• InjuryJul 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD HIP DONE ON (B)(6) 2017 AT THE HOSPITAL BY THE SURGEON. PATIENT HIP HAD RECENTLY BECOME DISLOCATED. THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM CONVERTING THE HIP TO A CONSTRAINED LINER FOR INCREASED STABILITY. A TRIAL REDUCTION WAS PERFORMED WITH A 60X36 +4 NEUTRAL TRIAL AND A 36MM +8.5 HEAD TRIAL. THIS WAS FOUND TO BE STABLE. THE REAL LINER AND FEMORAL HEAD WAS OPENED AND IMPLANTED. HIP WAS REDUCED AND THE LOCKING RING WAS PLACED APPROPRIATELY. HIP STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17324349 ↗
• InjuryApr 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD DISLOCATION DUE TO PATIENT SPECIFIC SPINAL LIMITATION TO MOVEMENT. CUP REMOVED AND PUT IN AN ORIENTATION MORE BENEFICIAL TO THIS PATIENT. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 16777141 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED IONS LEVEL AND PAIN. PRIMARY IMPLANTS WERE PINNACLE MOM. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 16539265 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD I AND D FOR INFECTION WITH HEAD AND POLY EXCHANGE. THERE WAS NO SURGICAL DELAY. DOI: APRIL 25,2022. DOR: MAY 23,2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14622684 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD THA ON (B)(6) 2021. THE SURGEON IMPLANTED A SUMMIT / PINNACLE HIP CONSTRUCT. THE PATIENT BEGAN TO EXPERIENCE PAIN AND DISCOMFORT WITH DRAINAGE IN AND AROUND THE WOUND. THE SURGEON EXPLANTED THE HIP CONSTRUCT AND IMPLANTED A PROSTALAC HIP CONSTRUCT. NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort; Fluid Discharge; Pain

  MAUDE report 13251255 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Pain

  MAUDE report 13236812 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SALES CONSULTANT WAS CALLED THIS AM BY THE OR THAT THERE WAS AN I&D WITH THE SURGEON. HE ARRIVED JUST AFTER THE INCISION WAS MADE AND WAS ABLE TO OBTAIN SOME INFORMATION REGARDING THE CASE. THIS PATIENT WAS TOLD TO COME INTO THE ER TO BE ADMITTED AND WOULD UNDERGO A HIP I&D. THIS PATIENT HAD HIS HIP REPLACED ON (B)(6) 2021 AT (B)(6) HOSPITAL AND RECENTLY BEGAN EXPERIENCING REDNESS AND DRAINAGE FROM HIS WOUND. DURING THE I&D THE HIP BALL AND PINNACLE LINER WERE EXPLANTED AND EXCHANGED FOR NEW PRODUCTS. THE 7HI SUMMIT STEM AND 60MM PINNACLE SECTOR CUP WERE LEFT IN SITU. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Erythema; Fluid Discharge

  MAUDE report 11619590 ↗
• InjuryMar 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD AND LINER EXCHANGE DUE TO INSTABILITY AND DISLOCATION. PINNACLE LINER WAS REMOVED AND REPLACED WITH A DUAL MOBILITY CONSTRUCT. COMPETITORS HEAD WAS EXCHANGED FOR A 28 MM HEAD. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 11463677 ↗
• InjuryFeb 17, 2021Device Dislodged or Dislocated

  AD (B)(6) 2021: UNFILLED CLAIM AND THE MEDICAL RECORD RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RIGHT HIP INFECTION AND SEVERE METALLOSIS WITH NONVIABLE INNOMINATE BONE, NONVIABLE PSOAS HIP ADDUCTORS, AND ABDUCTORS, AND STATUS POST OSTEOMYELITIS INCLUDING FUNGAL OSTEOMYELITIS. OPERATIVE NOTE REPORTED SEVERE SOFT TISSUE AND BONE NECROSIS. ON (B)(6) 2020, THE PATIENT UNDERWENT HIP REDUCTION DUE TO DISLOCATION, HIP PAIN, AND ATRIAL FIBRILLATION. THE PATIENT UNDERWENT A SECOND REVISION ON (B)(6) 2020, WITH THE NON-DEPUY PRODUCT INVOLVED. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP (THIRD REVISION). PLEASE SEE (B)(4) THAT CAPTURED THE FIRST REVISION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia; Distress; Foreign Body Reaction; Joint Dislocation; Joint Laxity; Loss of Range of Motion; Necrosis; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11339076 ↗
• InjuryAug 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED AS HEAD AND LINER EXCHANGE PERFORMED FOR A DISLOCATED TOTAL HIP REPLACEMENT. DOI: (B)(6) 2020. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10414014 ↗
• InjuryJun 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO LINER DISASSOCIATION, LINER FAIL. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 10191940 ↗
• InjuryJan 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR LINER DISASSOCIATION. PATIENT HAD DISLOCATED AND POLY DISASSOCIATED. DOI: (B)(6) 2020; DOR: (B)(6) 2020; (UNKNOWN HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9633805 ↗