PINNACLE 1218-28-748Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295011521), received between Feb 1, 2018 and Sep 10, 2026 — classified as 18 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the mode of failure is instability. A revision of the head and liner components was performed in effort to achieve a stable construct.DOI: (b)(6)2019.DOR: (b)(6)2026.Affected side: Unknown.

  Patient problems: Joint Laxity

  MAUDE report 50720563 ↗
• InjuryAug 17, 2026Device Dislodged or Dislocated; Naturally Worn

  It was reported that the patient had a dislocation of her hip. Head and Liner were replaced without delay nor patient harm being noted. Wear was present on the poly liner which likely resulted in the hip being able to escape from the constrained liner. The new liner was placed in an orientation to minimize impingent. Affected Side: Left Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50274361 ↗
• InjuryApr 29, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25036040 ↗
• InjuryJan 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT PRESENTS IN ER WITH DISLOCATED HIP POST TOTAL FEMUR REPLACEMENT. HEAD AND LINER WERE REPLACED WITH NO DELAY NOR PATIENT HARM. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24007120 ↗
• InjurySep 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PROCEDURE WAS THE FOURTH PROCEDURE ON THIS PATIENT'S RIGHT HIP. PATIENT INITIALLY FRACTURED HIP, FOR WHICH BIPOLAR COMPONENTS WERE USED TO REPAIR HIP. THEN THE PATIENT UNDERWENT A SECOND PROCEDURE THREE MONTHS LATER TO CONVERT BIPOLAR HIP TO A TOTAL HIP, DUE TO DISLOCATIONS BECAUSE OF INSTABILITY. DURING THIS THIRD PROCEDURE, THE PATIENT'S ACETABULAR LINER AND FEMORAL HEAD WERE SWAPPED OUT FOR A CONSTRAINED ACETABULAR LINER AND HEAD, DUE TO CONTINUED DISLOCATIONS AND INSTABILITY. DURING THIS FOURTH PROCEDURE, PATIENT'S CONSTRAINED ACETABULAR LINER AND FEMORAL HEAD WERE SWAPPED OUT A SECOND TIME DUE TO ANOTHER DISLOCATION. PATIENT HIP HAD DISLOCATED ONCE AGAIN, EVEN THOUGH THE CONSTRAINED LINER LOCKING RING WAS STILL IN PLACE. DURING TODAY'S PROCEDURE, THE DOCTOR WAS UNABLE TO FULLY SEAT THE LOCKING RING FOR THE FIRST CONSTRAINED LINER IMPLANTED. DOCTOR THEN SWAPPED IT OUT FOR A SECOND CONSTRAINED LINER, SINCE DR. HAD DAMAGED THE POLYETHYLENE PORTION OF THE FIRST LINER WHILE ATTEMPTING TO SEAT THE LOCKING RING. UNFORTUNATELY, DR. WAS ALSO UNSUCCESSFUL IN ATTEMPTS TO FULLY SEAT THE SECOND LOCKING RING INTO THE SECOND LINER. AFTER NUMEROUS ATTEMPTS TO SEAT TH

  Patient problems: Joint Dislocation

  MAUDE report 22963338 ↗
• InjuryJul 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED, THE FEMORAL HEAD AND THE CONSTRAINED LINER NEEDS TO BE EXPLANTED. NEW IMPLANTS WERE PUT IN THEIR PLACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22394184 ↗
• InjuryMar 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT GOT DISLOCATED WITH A CONSTRAINED LINER THAT WAS IMPLANTED IN 2015 AT A HOSPITAL. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21542066 ↗
• MalfunctionJun 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD MULTIPLE SURGERIES, CHRONIC DISLOCATIONS. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19578416 ↗
• InjuryMay 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO A DISLOCATED HIP POST TOTAL FEMORAL REPLACEMENT WITH A CONSTRAINED LINER. LINER AND HEAD ARE REPLACED UNEVENTFULLY WITH NO DELAY OR PATIENT HARM NOTED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 19221442 ↗
• InjuryApr 1, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED: WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO WAS THERE ANY ALLEGATION AGAINST THE CUP, APEX HOLE AND SCREW? NO.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 19014091 ↗
• InjuryOct 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 17994379 ↗
• InjuryOct 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE CONSTRAINT LINER WAS DISLOCATED, WHICH WAS REMOVED AND REPLACED. THE HEAD WAS REVISED TO A LONGER HEAD. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17879207 ↗
• InjuryJun 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CONSTRAINED LINER HAD BEEN IMPLANTED AND WAS SITTING IN THE ACETABULAR SHELL COMPONENT. WHILE THE SURGEON WAS TRYING TO REDUCE THE HIP, THE LIP OF THE CONSTRAINED LINER WAS COMPROMISED. THE SURGEON THINKS THAT THE FORCE OF THE FEMORAL HEAD BALL HITTING THE LIP OF THE LINER BEFORE IT WAS REDUCED IS WHAT CAUSED THE MALFUNCTION.

  Patient problems: Joint Dislocation

  MAUDE report 17098129 ↗
• MalfunctionJun 8, 2023Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT AFTER TRYING TO REDUCE THE HIP, THE SURGEON NOTICED THAT THE LIP OF THE LINER HAD DEFORMED (HAD EITHER BROKEN OR BEEN COMPROMISED) MAKING IT IMPOSSIBLE TO REDUCE THE HIP. THE LINER WAS NOT COMPROMISED WHEN IT WAS OPENED AND INITIALLY IMPLANTED. THE SURGEON THINKS THIS HAPPENED WHILE TRYING TO REDUCE THE HIP.

  Patient problems: Insufficient Information

  MAUDE report 17092581 ↗
• InjuryDec 6, 2022Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  SURGEON INFORMED ME THIS PATIENT HAD DISLOCATED WITH A CONSTRAINED LINER IMPLANTED. THE FEMORAL HEAD HAD COMPLETELY PULLED OUT OF THE LOCKING RING OF THE LINER, LEAVING THE LINER ENGAGED INTO THE CUP. SURGEON WAS UNSURE IF THE INITIAL SURGERY DATE AND WHAT SURGEON HAD PERFORMED THE SURGERY. HE ASKED THAT WE HAVE DUAL MOBILITY OPTIONS, AS WELL AS CONSTRAINED LINER OPTIONS AVAILABLE FOR A REVISION. THE CONSTRAINED LINER WAS REMOVED, AND SURGEON REALIZED THE +4/10 DEGREE CONSTRAINED LINER HAD THE 10 DEGREE HOOD FACING IN RETROVERSION. HE FELT THIS WOULD DO BETTER IMPLANTED IN ANTEVERSION. A NEW 48X28 +4/10 DEGREE CONSTRAINED LINER WAS TRIALED WITH A 28MM +5 HEAD. THE HIP WAS REDUCED AND FOUND TO BE STABLE. THE REAL IMPLANTS WERE OPENED AND IMPLANTED. HIP WAS THEN REDUCED AND STABILITY WAS CONFIRMED. CLOSING PROCESS BEGAN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15925675 ↗
• MalfunctionAug 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CONSTRAINED LINER BENT DURING WHAT SHOULD HAVE BEEN A RATHER ROUTINE REDUCTION AND THUS COULD NOT BE IMPLANTED. RESULTED IN REMOVAL OF THE CONSTRAINED LINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273771 ↗
• MalfunctionMar 17, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  LIP OF CONSTRAINED 10 DEGREE POLY LINER BROKE WHEN THE HIP WAS BEING REDUCED. REASON FOR THE REVISION WAS DISLOCATION. SURGERY DELAYED DUE TO THE REPORTED 15 MINUTES.

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

  MAUDE report 11506191 ↗
• InjuryAug 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HIP REVISION, 2ND ONE. PATIENT HAD HIGH IRON LEVEL PRE OP. LINER EXCHANGE. METALLOSIS FOUND IN PATIENT. RING OF CONSTRAINT LINER IN SITU WAS OFF THE LINER.

  Patient problems: Foreign Body Reaction; Joint Dislocation; No Code Available

  MAUDE report 10471392 ↗
• InjurySep 16, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATION WITH HEAD ESCAPING THE CONSTRAINED LINER. DOI: (B)(6) 2018; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9070491 ↗
• InjuryJul 9, 2019Fracture; Fracture

  PATIENT RECEIVED A TOTAL HIP FOR FRACTURE ON (B)(6) 2018 AT (B)(6) HOSPITAL. PATIENT PRESENTED IN (B)(6) ER ON MONDAY, (B)(6) WITH A DISLOCATED HIP AND DR PERFORMED A CLOSED REDUCTION. DR. ELECTED TO CONSTRAIN THE SAME HIP THE NEXT DAY DUE TO WHAT HE EXPECTED WAS DEFICIENT ADDUCTORS. ON TUESDAY, (B)(6) DR PERFORMED REVISION SURGERY ON THE PATIENT. DR REMOVED THE INDEX ACETABULAR LINER AND FEMORAL HEAD. DR. THEN ASKED FOR A PINNACLE CONSTRAINED 48/28 +4 10 DEG LINER TO BE OPENED AND A ARTICULEZE 28MM +8.5 COCR FEMORAL HEAD TO BE OPENED AS WELL FOR IMPLANTATION. DR IMPLANTED THE CONSTRAINED LINER WITHOUT INCIDENT. HE THEN IMPACTED THE FEMORAL HEAD ONTO THE NATIVE STEM. UPON REDUCTION, DR STRUGGLED TO REDUCE THE HIP AND WAS UNSUCCESSFUL. DR REMOVED THE 28MM +8.5 COCR HEAD AND HAD A 28 +5MM COCR HEAD OPENED AND IMPACTED IT ON THE FEMORAL STEM. DR TRIED TO REDUCE THAT CONSTRUCT AND FOUND THAT HE HAD BROKEN ONE OF THE TABS ON THE PREVIOUSLY IMPLANTED CONSTRAINED LINER WHEN HE HAD TRIED TO REDUCE THE 28 +8.5MM FEMORAL HEAD AND THAT IT WOULD NOT ACCEPT THE 28 +5MM FEMORAL HEAD. DR THEN ELECTED TO REMOVE THE CONSTRAINED LINER AND REPLACE IT WITH ANOTHER CONSTRAINED LINER (PINNACLE 48/28 +4

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8770992 ↗
• InjuryMar 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT IS CONTINUALLY DISLOCATING, REFERENCE COMPLAINT (B)(4). REMOVED CUP AND LINER/HEAD TO PUT IN NEW CUP AND DUAL MOBILITY. DOI: (B)(6) 2018 (FOR THE CUP); DOI: (B)(6) 2018 (FOR THE HEAD AND LINER); DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8429239 ↗
• InjuryFeb 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. SURGEON SAID THAT PATIENT HAS BEEN A CHRONIC DISLOCATOR SINCE 2012 AND PATIENT HAD A PRIOR REVISION 2 YEARS AGO. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7233580 ↗