PINNACLE 1218-28-648Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10603295011507), received between Sep 7, 2017 and Jan 30, 2026 — classified as 56 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (39 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 24221921 ↗
• InjuryDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS A HEAD AND LINER EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23865956 ↗
• InjuryNov 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND UNDERWENT REVISION SURGERY FOLLOWING DISLOCATION OF CONSTRAINED LINER HIP. DURING SURGERY THE LOCKING RING WAS FOUND TO HAVE CRACKED ON THE CONSTRAINED LINER. PATIENT ALSO HAD SOME METALLOSIS IN THE HIP REGION. PATIENT WAS REVISED WITH DEPUY DUAL MOBILITY HIP LINER AND NEW CERAMIC HEAD FOR STABILITY. NO FURTHER INFORMATION AVAILABLE ON HOW HIP DISLOCATED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Joint Dislocation; Pain

  MAUDE report 23584845 ↗
• InjurySep 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 23072979 ↗
• MalfunctionSep 4, 2025Difficult to Insert; Difficult to Insert

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963339 ↗
• InjuryJul 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A CONSTRAINED LINER IN (B)(6) 2024 DUE TO AN ANTERIOR DISLOCATION. PATIENT REPORTED TO THE ER YESTERDAY WITH ANOTHER DISLOCATION. THE CONSTRAINED LINER WAS BROKEN WHERE THE CONSTRAINING RING MATES WITH THE LINER AND THE HEAD HAD DISASSOCIATED ANTERIORLY. THE CONSTRAINING RING WAS IN PROPER ORIENTATION (CHAMFER TOWARDS ACETABULUM). CUP WAS EXPLANTED AND REVISED TO A LARGER CUP, ALLOWING A BETTER/LARGER DM OPTION OVER CONSTRAINED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22620691 ↗
• InjuryJul 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATED HIP. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22566426 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND INSTABILITY. SURGEON CHOOSE TO TAKE THE PATIENT TO SURGERY FOR A REVISION OF LEFT TOTAL HIP. DOCTOR FOUND THE ACETABULAR SHELL SLIGHTLY MORE RETROVERTED THAN HE PREFERS. THE STEM WAS FOUND TO BE SOLID AND WELL POSITIONED. DOCTOR REMOVED THE FEMORAL HEAD TO AID HIS EXPOSURE OF THE ACETABULUM. DOCTOR THEN REMOVED THE ACETABULUM SHELL AND REPLACED IT WITH HIS PREFERRED COMPETITOR SHELL. ONCE THE SHELL WAS DONE, A NEW HEAD BALL WAS CHOSEN. THROUGH THE RANGE OF MOTION THE PATIENT'S HIP APPEARED TO BE STABLE. THE SHELL, PINNACLE SECTOR WAS NOT LOOSE, RATHER MALPOSITIONED. DOCTOR FELT A BETTER CUP POSITION WOULD ELIMINATE THE HIP FROM DISLOCATING. THE PATIENT CLOSED IN HIS USUAL FASHION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22472554 ↗
• InjuryJul 1, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A PINNACLE CONSTRAINED LINER IMPLANTED IN 2022 FOR CHRONIC DISLOCATION. PATIENT BROKE THE POLY/RING LOCKING MECHANISM RECENTLY AND DISLOCATED AGAIN. DOCTOR ELECTED TO PUT A NEW PINNACLE CONSTRAINED LINER IN. DOCTOR HAD PUT IN A CONSTRAINED LINER IN 2012 AND AGAIN IN 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22370625 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REVISED DUE TO PAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. AFFECTED AREA: UNK HIP.

  Patient problems: Pain

  MAUDE report 22211701 ↗
• InjuryJun 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A DISSOCIATED RING. THERE WAS NO SURGICAL DELAY IN RELATION TO THE EVENT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22202618 ↗
• InjuryMay 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENTS CURRENT PINNACLE CONSTRAINED LINER DISLOCATED. THE FEMORAL HEAD DISLOCATED OUT OF THE CONSTRAINED LINER. THE CONSTRAINED LINER FEMORAL HEAD WAS REMOVED AND REPLACED. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 22061879 ↗
• InjuryApr 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT CONSTRAINED LINER GOT DISLOCATED. REPLACEMENT IS NOT NEEDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 21873018 ↗
• InjuryMar 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS DISLOCATED FROM CONSTRAINED INSERT. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 21712431 ↗
• InjuryDec 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS DONE IN A DIFFERENT HOSPITAL. THE PATIENT DISLOCATED SEVERAL TIMES. A CONSTRAINED LINER WAS IMPLANTED IN 2022. SHE DISLOCATED AGAIN ON (B)(6) 2024. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20821369 ↗
• InjuryOct 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 20351796 ↗
• InjuryJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED. THE SURGEON REMOVED THE HEAD AND LINER AND INSERTED NEW. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19752610 ↗
• InjuryJun 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. THE SURGEON REVISED TO A CONSTRAINED PINNACLE JUST DISLOCATED FROM LOCKED LINER AND PLAN TO CONVERT TO A DUAL MOBILITY, WHICH WASN'T AN OPTION IN 1/2 - NOTED NOTCHING ON FEMORAL NECK CONVERTED PINN. THERE WAS NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19568588 ↗
• InjuryJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A NEW CUP PLACED DUE TO FAILURE OF LOCKING MECHANISM OF A COMPETITIVE CUP ALONG WITH SUB OPTIMAL POSITIONING. THE SURGEON CHOSE NOT TO UTILIZE THE PROVIDED LOCKING RING TO REDUCE THE CHANCE OF THE CUP BEING PULLED OUT WHILE INGROWTH TOOK PLACE. PATIENT DISLOCATED YESTERDAY AND WAS BROUGHT TO THE OR AND A NEW LINER AND HEAD WERE PLACED WITH THE LOCKING RING WITHOUT DELAY OR PATIENT HARM. UNKNOWN SURGICAL DELAY. DOI: ON B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19460415 ↗
• InjuryFeb 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED. ALL IMPLANTS WERE REMOVED. THERE WAS NO ADDITIONAL TIME ADDED TO THE CASE. THE PATIENT WASN'T HARMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18704535 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLEASE CONFIRM WHY THE REVISION SURGERY WAS PERFORMED. -THOUGHT THE PATIENT MAY HAVE BEEN INFECTED, BUT NOT PHYSICAL EVIDENCE SEEN, MULTIPLE SPECIMENS TAKEN. WAS INFECTION CONFIRMED FOR BOTH REVISIONS ? I WAS NOT PRESENT AT THE FIRST REVISION, BUT I WOULD ASSUME SHE WAS DISLOCATING AND I AM ALSO UNAWARE OF THE SPECIMEN RESULTS, BUT AGAIN I WOULD ASSUME IT WAS AS PUSS WAS SEEN.

  Patient problems: Unspecified Infection

  MAUDE report 18685924 ↗
• InjuryNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT FELL AND DISLOCATED THE CONSTRAINED LINER. PATIENT WAS REVISED WITH THE SAME SIZE IMPLANTS. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 18184311 ↗
• InjurySep 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO HIP DISLOCATED DUE TO FALL SO DID HEAD LINER. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 17816177 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NO FURTHER INFORMATION WAS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 17022159 ↗
• InjuryApr 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. 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 16823473 ↗