PINNACLE 1217-20-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295009597), received between Oct 20, 2017 and May 13, 2025 — classified as 26 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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.

• MalfunctionMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REPLACEMENT SURGERY WAS PERFORMED FOR PREMATURELY WORN PE WITH REPLACEMENT OF THE HIP-HEAD AND PE. THERE WERE THREE YEARS OF INSUSPCIOUS PROGRESS, AND NOW SHORT-TERM PE WEAR WITH METAL-METAL CONTACT OCCURRED WITHIN A FEW MONTHS. REVISION WAS PERFORMED FOR CHANGING OF THE CUP AND HEAD. THIS PATIENT HAD UNDERGONE A PREVIOUS REVISION AFTER FOUR YEARS DUE TO PE WEAR IN 2021. AFFECTED SIDE: RIGHT HIP ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE REASON OF THE EXPLANT WAS WHENEVER A PE INLAY IS REVISED THE HEAD NEEDS TO BE EXCHANGED AS WELL.

  Patient problems: Insufficient Information

  MAUDE report 22013013 ↗
• InjuryApr 2, 2025Use of Device Problem; Use of Device Problem

  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: Insufficient Information

  MAUDE report 21754791 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. CAN YOU PLEASE PROVIDE THE AFFECTED SIDE? RIGHT HIP. B. WAS THE EXTEND OF THE SURGICAL DELAY? NO DELAY.

  Patient problems: Joint Laxity

  MAUDE report 18658220 ↗
• InjuryFeb 3, 2024Fracture; Fracture

  PATIENT WAS REVISED ON (B)(6) 2022 FOR UNKNOWN REASON, AND LATER RE-REVISED ON (B)(6) 2023, WHERE THE HEAD AND INSERT WERE REPLACED DUE TO METALLOSIS. NO SURGICAL DELAY REPORTED.

  Patient problems: Foreign Body Reaction

  MAUDE report 18637083 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR DISLOCATION. SURGEON EXPLANTED THE CUP, LINER, HEAD AND SCREW. REAMING WAS CONDUCTED TO INCREASE THE SIZE OF THE CUP. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17200024 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIP INSTABILITY WITH RECURRENT DISLOCATION.

  Patient problems: Joint Laxity

  MAUDE report 17152593 ↗
• InjuryJun 19, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PRIMARY SURGERY WAS PERFORMED VIA THA. ON (B)(6), 2023, IT WAS DETERMINED TO REVISE THE MOLAR SIDE AND TO PRESERVE THE SLEEVE ON THE FEMORAL SIDE. THE HEAD AND THE STEM WILL BE REPLACED. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023. THE REASON FOR THE REVISION AND THE EVENT DATE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17151497 ↗
• InjuryMay 18, 2023Use of Device Problem; Use of Device Problem

  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 16952210 ↗
• InjuryNov 9, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA FOR OA WITH IMPLANTS IN QUESTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT PRESENTED WITH HIP JOINT PAIN IN (B)(6) 2022. IT WAS CONFIRMED BY X-RAY THAT THE LINER WAS WORN OUT ON THE ACETABULUM SIDE, AND THE EDGE OF THE METAL CUP WAS IN CONTACT WITH THE CERAMIC FEMORAL HEAD. THEN, THE REVISION WAS PERFORMED ON (B)(6) 2022. THE FOLLOWING DEFECTS WERE FOUND IN REVISION SURGERY. THE SLIDING SURFACE OF THE LINER WAS UNEVENLY WORN OUT. THE LOCKING SURFACE OF THE LINER AND CUP WAS DAMAGED. THE FEMORAL CERAMIC HEAD AND THE ACETABULAR METAL CUP WERE ALSO IN CONTACT, AND METAL POWDER WAS GENERATED DUE TO PARTIAL WEAR. THE LINER AND HEAD WAS REPLACED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. DOI: (B)(6) 2015, DOR: (B)(6) 2022, UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 15758858 ↗
• MalfunctionJun 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER A X-RAY, IT WAS DETECTED A DISLOCATION OF THE PE INSERT AFTER 13 DAYS FROM THE REVISION SURGERY OF THE (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14566590 ↗
• InjuryFeb 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO ACETABULAR CUP AND LINER NOT FITTING PROPERLY. TWO SEPARATE REVISIONS WERE COMPLETED TO ADDRESS THE ISSUE. DOI: (B)(6 )2018. DOR: (B)(6) 2021. DOR: (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 13600722 ↗
• InjuryJun 22, 2021Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  ON (B)(6) 2017, THE PATIENT UNDERWENT A PRIMARY RIGHT HIP ARTHROPLASTY DUE TO ADVANCED COXARTHROSIS WITH EXISTING DYSPLASIA. DEPUY ACETABULAR CUP, POLY LINER, DEPUY CORAIL STEM, AND METAL HEAD WERE IMPLANTED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT HIP REVISION TO ADDRESS POLY LINER WEAR. THE SURGEON NOTED SUBLUXATION THAT WAS CAUSING NOISES. THE HEAD AND LINER WERE REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

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

  MAUDE report 12040311 ↗
• InjuryOct 27, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; 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 10740701 ↗
• InjurySep 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT IMPLANTS WERE RECEIVED WITH AN ALLEGATION OF DISASSOCIATION OF THE LINER FROM THE CUP. DOI: UNKNOWN. DOR: UNKNOWN; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 10587281 ↗
• InjuryFeb 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE INLAY DISLOCATED. A REVISION HAD TO BE PERFORMED.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9666876 ↗
• InjuryJan 13, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT DESCRIBED PAIN AND INSTABILITY IN LEFT HIP. XRAY SHOWED THE CUP TO BE IN A VERTICAL POSITION AND HAD AUREOLE WEAR OF THE POLY. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9581951 ↗
• InjuryJan 9, 2020Use of Device Problem; Malposition of Device; Device Dislodged or Dislocated; Use of Device Problem; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER DISASSOCIATED FROM SHELL. THE CUP WAS PULLED BECAUSE IT WAS VERTICAL. DOI: (B)(6) 2015; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9569386 ↗
• InjuryDec 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DESCRIPTION OF THE INCIDENT: ONE MONTH AFTER THE PATIENT HAD A THA, THE HIP WAS LUXATED. THE LINER HAD LOOSEN FROM THE METAL CUP.

  Patient problems: Not Applicable

  MAUDE report 9483766 ↗
• InjuryNov 18, 2019Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  DR. SAW ONE OF HIS PATIENT AT A 5 YEAR FOLLOW UP. UPON TAKING X-RAYS HE NOTICED WHAT'S 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 9336517 ↗
• InjurySep 23, 2019Loss of Osseointegration; Loss of Osseointegration

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INFECTION OF THE RIGHT HIP. THERE WAS AN OPEN WOUND, SWELLING, PAIN AND PUS. OPERATIVE NOTE REPORTED PUS ENCOUNTERED, CUP WAS LOOSED, BONE STOCK EXTREMELY DEFICIENT AND PATIENT HAD A MULTIPLE ALLERGIES. SURGICAL PATHOLOGY REPORTED ACUTE INFLAMMATION AND NECROSIS CONSISTENT WITH ACUTE OSTEOMYELITIS OF THE IMPLANTS PORTIONS OF BONE ARE IRREGULARLY SHAPED AND MARKEDLY DISRUPTED WITH ATTACHED TAN-PINK TO RED BROWN SOFT TISSUES AND BLOOD CLOT. DOI: (B)(6) 2008; DOR: (B)(6) 2008; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Inflammation; Injury; Necrosis; No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 9107735 ↗
• InjuryJun 21, 2019Malposition of Device; Malposition of Device

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOCTOR DID A CUP REVISION USING A COMPETITIVE IMPLANT. DOI: (B)(6) 2004. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 8723777 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES DISLOCATION (WITH CLOSED REDUCTION), INFECTION, LOOSENING OF STEM AND ELEVATED METAL IONS. DOI: (B)(6) 2013 - DOR: (B)(6) 2014, (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8549019 ↗
• InjuryJan 7, 2019Positioning Problem; Separation Problem; Positioning Problem; Separation Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING PAIN AND CLICKING OR POPPING WHEN SHE WALKED. THE X-RAYS SHOWED THAT SHE WORE THROUGH THE POLY INSERT. UPON REMOVING THE LINER, IT WAS BROKEN. SURGERY PERFORMED AND LINER AND HEAD "EXCHANGE".

  Patient problems: No Code Available; Pain

  MAUDE report 8222047 ↗
• InjuryDec 28, 2018Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE AD 07 MAY 2018: THE RECEIPT OF PPF AND IMPLANT RECORD. IN ADDITION IN WHAT WAS PREVIOUS ALLEGED. PPF ALLEGES LOOSENING OF CUP AND METAL WEAR/METALLOSIS.

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain

  MAUDE report 8202313 ↗
• InjuryFeb 21, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IMPLANT HAD TO BE REVISED DUE TO LUXATION BETWEEN CUP AND LINER. DOI: UNKNOWN ; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7285531 ↗