PINNACLE 1218-36-658Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295012139), received between Sep 8, 2017 and Nov 24, 2025 — classified as 31 injuries, 3 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PIN LNR CONS NEUT +4 36IDX58OD AND PINN LNR CON +4 10D 36IDX58OD WERE INVOLVED IN AN EVENT WHERE THE LINERS DISSOCIATED FROM THE ACETABULAR SHELL. THE PATIENT REQUIRED REVISION SURGERY DUE TO POST-OPERATIVE DISSOCIATION OF THE FIRST LINER, AND THE NEWLY IMPLANTED LINER ALSO DISSOCIATED DURING THE SAME PROCEDURE, NECESSITATING FURTHER REVISION. THE EVENT WAS ASSOCIATED WITH THE LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 23630262 ↗
• InjuryOct 24, 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. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23383221 ↗
• MalfunctionJun 6, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT A PINNACLE CONSTRAINED LINER WAS PUT INTO A PINNACLE GRIPTION CUP. THE HEAD BALL WAS PUT IN THE CONSTRAINED LINER AND THE CONSTRAINING RING WAS PLACED ON THE LINER. THE SURGEON WAS ABLE TO ¿SPIN¿ THE RING. HE WAS ALSO ABLE TO INSERT THE TIP OF THE BOVIE BETWEEN THE RING AND THE FACE OF THE CONSTRAINED LINER. THE RING WAS NOT COMING OFF THE LINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157728 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HIP I & D PERFORMED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22015190 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT SORRY THE LOT NUMBER WAS NOT LEGIBLE. NO ADVERSE EVENT OR REACTION. UNSURE OF LOT ON THE CUP AS IT WAS NOT LEGIBLE. NO DELAY.

  Patient problems: Joint Laxity

  MAUDE report 21297354 ↗
• InjuryJun 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD REVISION OF CONSTRAINED LINER AND FEMORAL HEAD DUE TO DISLOCATION. THERE WAS NO DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19605233 ↗
• InjuryJan 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO HIP DISLOCATION WHILE IN PHYSICAL THERAPY. SURGEON EXPLANTED LINER REVISING WITH NEW CONSTRAINED CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18576085 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN FROM PREVIOUS HEAD AND LINER EXCHANGE. SURGEON REMOVED HEAD AND LINER, CONDUCTED A WASHOUT AND REPLACED WITH THE SAME HEAD AND LINER AS PREVIOUSLY USED. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18534163 ↗
• InjuryAug 23, 2023Noise, Audible; Noise, Audible

  ON (B)(6) 2017 STATES THE PATIENT IS HAVING RIGHT HIP PAIN WITH POPPING AND GRINDING (CREPITUS) WHEN EXERCISING. PATIENT WAS DIAGNOSED WITH RIGHT GREATER TROCHANTER BURSITIS AND WAS GIVEN A CORTISONE INJECTION. ON (B)(6) 2017, HE CONTINUES TO HAVE MILD PAIN WITH PALPATION OVER THE RIGHT GREATER TROCHANTER BUT ONLY RECOMMENDED INTERVENTION IS STRETCHING AND ICE. ON (B)(6) 2018, HE CONTINUES TO HAVE MILD PAIN OVER THE RIGHT GREATER TROCHANTER AFTER EXTENDED WALKING AND WILL CONTINUE STRETCHES AND ICE. ON (B)(6) 2021, THE PATIENT STATES HE HAS PAIN AND SWELLING IN HIS RIGHT HIP AND IS TREATING WITH ICE AND TYLENOL. ON (B)(6) 2022, AN ULTRASOUND SHOWS A LARGE FLUID COLLECTION IN THE AREA OF THE TROCHANTERIC BURSA. ASPIRATION AND POSSIBLE PHYSICAL THERAPY IS CONSIDERED THOUGH NO NOTES INDICATE THE ASPIRATION OCCURRED. ON (B)(6) 2022, PATIENT UNDERGOES A SERIOUS OF PHYSICAL THERAPY TREATMENTS FOR THE ONGOING SWELLING AND PAIN OVER THE RIGHT HIP. DOI: (B)(6) 2013; DOR: UNREVISED; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 17602608 ↗
• MalfunctionJul 24, 2023Fracture; Difficult to Remove; Fracture; Difficult to Remove

  ADDITIONAL INFORMATION RECEIVED. A. PLEASE VERIFY IF THERE WAS ANY PATIENT HARM OR ADVERSE EVENT INVOLVED? INCREASE IN SURGERY TIME BY 1HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17380113 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD MULTIPLE SURGERIES. ON (B)(6) 2021 HEMI ARTHROPLASTY WAS DONE AND STEM REMAINS FROM THIS PROCEDURE. ON 9/19/21 HIP DISLOCATED AND CONVERTED TO CONSTRAINED TOTAL HIP BY SURGEON. ON 12/14/21 CUP WAS REVISED AND DUAL MOBILITY WAS PLACED BY SURGEON. DER WAS FILED, CUP AND SCREW THAT LISTED ON THE DER, PLACED AT THIS TIME. ON (B)(6) 2022 IT WAS CONVERTED TO DM TO CONSTRAINED DUE TO DISLOCATION. DER WAS SUBMITTED, HEAD AND LINER PLACED AT THIS TIME. PATIENT PRESENTS IN ER WITH A PERIPROSTHETIC FACTURE OF RIGHT HIP WITH APPEARANCE OF POSSIBLE INFECTION SUPERIOR TO ACETABULAR COMPONENT. ALL COMPONENTS REMOVED AND PROSTALAC PLACED UNEVENTFULLY. THERE WAS LOOSENING OF FEMORAL COMPONENT POST FACTURE AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16859923 ↗
• InjuryApr 24, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATED CONSTRAINED LINER. WORE THROUGH POLY. REPLACED WITH NEW ONE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16794277 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI- UNKNOWN; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT HIP.

  Patient problems: Pain

  MAUDE report 14159199 ↗
• InjuryAug 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION AND THE SURGEON OPTED FOR REVISION SURGERY WITH A DUAL MOBILITY CUP. PATIENT WAS STABLE WHEN LEAVING THE O.R. DOI: (B)(6) 2021. DOR: (B)(6) 2021. (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 12385111 ↗
• InjuryDec 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO THE FEMORAL COMPONENT AND HEAD DISLOCATED FROM CONSTRAINED LINER. THE LINER LOCKING RING WAS INTACT ON THE POLY LINER. REVISED TO PINNACLE DUAL MOBILITY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11089801 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10793629 ↗
• InjuryOct 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED AS LINER AND HEAD REVISION DUE TO DISLOCATION. PINNACLE CONSTRAINED LINER WAS REMOVED AND REPLACED WITH A COMPETITOR CONSTRAINED LINER AND DEPUY HEAD. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10665881 ↗
• InjuryAug 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT HEAD AND LINER EXCHANGE DUE TO RECURRENT DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10471452 ↗
• InjuryJun 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION, WAS THE SURGEONS TECHNIQUE OF CHOICE DUE TO THE FACT THAT THE PATIENT HAD PREVIOUSLY DISLOCATED HIS HIP. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10178354 ↗
• InjuryMar 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT CAME THROUGH THE EMERGENCY ROOM WITH DISLOCATION DUE TO TWISTING MOTION. DOI: (B)(6) 2016. DOR: (B)(6) 2020. AFFECTED SITE: UNKNOWN.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9868365 ↗
• InjuryNov 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AFTER THE FIRST REVISION. DOI: (B)(6) 2017 - DOR: NONE REPORTED (LEFT HIP, SECOND EVENT).

  Patient problems: Joint Dislocation

  MAUDE report 9315602 ↗
• InjuryJun 21, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED HER CONSTRAINED LINER. DURING THE REVISION, THE LINER WAS REMOVED AND DISCOVERED TO HAVE A CRACK ON THE OUTER ELEVATED EDGE OF THE POLY. THE LOCKING RING WAS OBSERVED TO BE STILL IN PLACE ON THE EXTERIOR OF THE POLYAND THE 36 TS FEMORAL HEAD WAS STILL ATTACHED TO THE FEMORAL STEM. CONSTRAINED LINER WAS DESTROYED DURING THE REMOVAL PROCESS BY THE SURGEON. THE SURGEON CHOSE TO REMOVE THE FEMORAL STEM, WHICH WAS WELL-FIXED, FOR A MODULAR REVISION STEM IN ORDER TO INCREASE FEMORAL ANTEVERSION. REVISED TO A TRIPOLAR. NO HISTORY OF FALLS OR ADDITIONAL EXPLANATION FOR THE DISLOCATION. DOI: (B)(6) 2019; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8724075 ↗
• InjuryJun 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP DISLOCATED, BUT CONSTRAINED LINER WITH LOCKING RING WERE INTACT. THE SURGEON WANTS TO KNOW HOW THE HIP DISLOCATED WITH CONSTRAINED LINER STILL ENGAGED IN CUP. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8662777 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL THA AND SEROMA. REVISION NOTES REPORTED OF LARGE VOLUME OF BROWNISH-TINGED FLUID AND GRANULATION TISSUE. THERE WAS SOME EROSION OF CALCAR OF BONE STOCK. THE STEM AND CUP WERE INTACT. THERE WAS ALSO AN EXTENSION OF PSEUDOTUMOR SEROMA. DOI: (B)(6) 2011 - DOR: (B)(6) 2013, (RIGHT HIP).

  Patient problems: Erosion; No Code Available; Pain; Seroma; Tissue Damage

  MAUDE report 8460028 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8063708 ↗