PINNACLE 1218-28-750Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295011538), received between Jul 18, 2017 and Aug 3, 2026 — classified as 40 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (29 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50117332 ↗
• InjuryJul 27, 2026Difficult to Insert

  It was reported the Constrained Liner had trouble seating into a Gription Multi-Hole Shell. The Liner sat slightly product anteriorly and could not be impacted further; the Liner was damaged while being removed, but was able to be removed. A second Constrained Liner was attempted and had the same issues.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035446 ↗
• InjuryFeb 17, 2026Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -NO. B. PLEASE CONFIRM WAS THERE PREVIOUS REVISION/S DUE TO MULTIPLE DISLOCATIONS? IF YES, WAS THIS REPORTED? PLEASE PROVIDE THE REFERENCE NUMBER. IF NO, PLEASE PROVIDE FURTHER DETAILS. -YES REVISED ON (B)(6) 2025, AND AGAIN ON (B)(6) 2025 TO A CONSTRAINED LINER. C. WAS THERE ANY ALLEGATION AGAINST THE CUP AND STEM? -NO. D. PLEASE CONFIRM HOW MANY PREVIOUS SURGERIES HAPPENED. -4. E. PLEASE PROVIDE REASON WHY THE STEM/CUP WAS REVISED, WAS THERE AN INDICATION THAT THE STEM/CUP WAS MALPOSITIONED THAT CONTRIBUTED TO DISLOCATION? -ONLY THE POLY AND HEAD WAS REVISED. F. PLEASE CLARIFY IF THE PREVIOUS MULTIPLE SURGERIES FOR DISLOCATION INVOLVED REMOVAL OF DEPUY PRODUCTS. IF YES, WAS THIS REPORTED? PLEASE PROVIDE THE REFERENCE NUMBER. IF NO, PLEASE PROVIDE FURTHER DETAILS. -YES, EVERY REVISION WAS A HEAD AND LINER EXCHANGE TO MAKE THE HIP MORE STABLE.

  Patient problems: Joint Dislocation

  MAUDE report 24363534 ↗
• InjuryDec 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED A CONSTRAINED LINER. THERE WAS LOOSENING OF THE CUP AT THE NON-CEMENTED INTERFACE. THERE WERE NO DELAY, OR NO HARM TO PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE FOR REPORTING. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23795203 ↗
• InjuryDec 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF HIP FROM CONSTRAINED LINER. SURGEON SAID THE PATIENT STEM AND CUP WERE NOT ALIGNED CORRECTLY BUT GIVEN ITS AGE SURGEON DID NOT WANT TO REMOVE THE IMPLANTS. SURGEON DID NOT DO THE PRIMARY SURGERY AND BELIEVED CHANGING OUT FOR THE SAME CONSTRAINED LINER SHOULD KEEP PATIENT STABLE. SURGEON SAID NOTHING LOOKED WRONG WITH OUR COMPONENTS JUST THAT THEY WERE NOT ALIGNED CORRECTLY. BOTH WERE IN RETROVERSION. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23790443 ↗
• InjuryJul 15, 2025Adverse 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 WITH POLY AND HEAD SWAP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22507068 ↗
• MalfunctionJul 14, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED THAT DURING THE REDUCTION OF THE HIP, THE SURGEON BROKE ONE OF THE POLY SLITS. AS A RESULT, THE FEMORAL HEAD COULD NO LONGER LOCK INTO THE LINER. THERE WAS LOOSENING OF THE CONSTRAINED LINER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500536 ↗
• InjuryJun 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT IMPLANTS NEEDED TO BE REVISED BECAUSE HIP WAS DISLOCATING AND UNSTABLE. PATIENT NEEDED A CONSTRAINED LINER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22345830 ↗
• InjuryJan 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD CAME THROUGH CONSTRAINED POLY DURING PT. ADDING LENGTH. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16112840 ↗
• InjuryMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. SURGEON EXPLANTED HEAD AND CONSTRAINED LINER REVISING WITH NEW CONSTRAINED LINER AND HEAD. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14352726 ↗
• InjuryMay 10, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  PPF, PFS AND MEDICAL RECORDS RECEIVED. PPF ALLEGES COMPONENT FRACTURE, DISLOCATION WITH CLOSED REDUCTION, AND ELEVATED METAL IONS. PFS ALLEGES HIP DISLOCATION, BONE AND MUSCLE DAMAGE, PAIN AND LIMITED RANGE OF MOTION. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC HIP RECURRENT INSTABILITY, DISLOCATION, DISRUPTION OF CONSTRAINED LINER WITH SUBLUXED, EXTENSIVE OSTEOLYSIS IN THE FEMUR AND ACETABULUM AND SLIGHTLY ELEVATED METAL IONS. OPERATIVE NOTE REPORTED SOME MODERATE TENDINOPATHY DUE TO METAL WEAR DEBRIS FROM OLD SURGERY, SCAR TISSUES AROUND THE ACETABULUM AND FEMUR. SOME METAL PIECES NOT RECOVERED DUE TO RISK DAMAGE THE SCIATIC NERVE AND VITAL STRUCTURES. ACETABULAR DEVICE HAD SIGNIFICANT AMOUNT OF ANTEVERSION; SUMMIT STEM WAS IMPINGING THE POSTERIOR RIM OF THE CUP. THERE WAS A MODERATE SIZE NOTCH ON THE STEM. DOI: (B)(6) 2018. DOR: (B)(6) 2021. RIGHT HIP 2ND REVISION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation; Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Physical Asymmetry; Scar Tissue; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 14349474 ↗
• InjuryApr 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO LOOSENING OF THE LOCKING RING WHICH CAUSED CONSTRAINED LINER AND LOCKING RING DISASSOCIATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 14102194 ↗
• InjuryOct 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12561702 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION. THE PATIENT WENT THROUGH SEVERAL I&DS AND WOULD NOT GET BETTER. THE SURGEON DECIDED TO DO A HIP DISARTICULATION. THE STEM, LINER AND CUP HAD TO COME OUT. THERE WERE NO INSTRUMENTS BROKEN OR DAMAGED. ALL COMPONENTS WERE REMOVED. DOI: (B)(6) 2021. DOR: (B)(6) 2021. (LEFT HIP).

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

  MAUDE report 12517277 ↗
• InjurySep 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HEAD WAS A DEPUY PRODUCT AND WAS REVISED BECAUSE THEY WENT TO A DUAL MOB.

  Patient problems: Joint Dislocation

  MAUDE report 12413432 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO OR DUE TO NON-HEALING WOUNDS POST-TREATMENT FOR RECURRENT INFECTION. MODULAR COMPONENTS WERE EXCHANGED, ANTIBIOTIC AND ANTI-FUNGAL BEADS WERE PLACED. DOI: (B)(6) 2021. DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 12354144 ↗
• InjuryJun 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE UNKNOWN. PATIENT SUFFERED A HIP DISLOCATION OF SROM HIP AND CONSTRAINED LINER. SURGEON WAS NOT AWARE OF THE PATIENTS PREVIOUS SURGICAL DATES OR REASONS FOR SURGERY. SURGEON FELT THIS PATIENT WAS DEALING WITH SOME HIP IMPINGEMENT OF THEIR +4/10 DEGREE CONSTRAINED LINER ON THE NECK OF THE SROM STEM. HE FELT THEY WOULD BENEFIT FROM CONVERTING THE LINER TO JUST A +4 NEUTRAL CONSTRAINED LINER. HE ALSO FELT THE PATIENT WOULD BENEFIT FROM REPLACING THE STEM SO HE COULD ADJUST THE VERSION A BIT. A TRIAL REDUCTION WAS PERFORMED WITH THE NEW STEM AND A +4 NEUTRAL CONSTRAINED LINER AND A 28MM +3 HEAD WAS FOUND TO BE SATISFACTORY. THE REAL LINER AND HEAD WERE OPENED AND IMPLANTED. THE HIP WAS REDUCED AND FOUND TO BE STABLE. THE CLOSING PROCESS BEGAN. DOI: UNKNOWN; DOR: (B)(6) 2021 (RIGHT HIP).

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

  MAUDE report 12003085 ↗
• InjuryJun 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2021, DR REMOVED A GRIPTION ACETABULAR CUP, 2 PINNACLE SCREWS, A PINNACLE MARATHON INSERT, AND A TS REVISION HEAD. THESE COMPONENTS WERE REPLACED BY ANOTHER TS REVISION HEAD, AND A COMPETITOR ALL POLY CEMENTED CUP. REASON FOR REVISION. PATIENT DISLOCATION. SURGEON STATED THIS DISLOCATION WAS UNEXPLAINED AND THAT PATIENT WAS "IN BED". NO FALL REPORTED. OPERATIVE SIDE: RIGHT. NO X-RAYS OR PATIENT NOTES AVAILABLE. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2021 AT (B)(6) HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 11998912 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS ALSO OPERATED ON ON (B)(6) 2017. AN DER WAS REPORTED AT THAT TIME PATIENT HAS HISTORY OF RECURRENT INFECTION AND SEVERE PSORIATIC ARTHRITIS. PATIENT PRESENTS WITH PAIN AND XRAYS REVEALING VISIBLE GAS IN XRAYS, LEADING SURGEON TO BELIEVE PATIENT IS INFECTED. ALL COMPONENTS EXCEPT THE CUP WERE REMOVED. SURGEON FELT THAT IF THE CUP WERE REMOVED, THERE WAS NOT ENOUGH BONE TO PLACE ANOTHER SHELL INTO. A THOROUGH DEBRIDEMENT AND SUBSEQUENT IRRIGATION WAS PERFORMED. A NEW SET UP WAS UTILIZED TO REIMPLANT THE PATIENT ALONG WITH PLACEMENT OF ANTIBIOTIC BEADS. SURGEON ALSO COATED EXPOSED IMPLANTS WITH HIGH DOSE ANTIBIOTIC CEMENT. DOI: (B)(6) 2017 DOR: (B)(6) 2021 LEFT HIP

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

  MAUDE report 11939005 ↗
• InjuryMay 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED HER CONSTRAINED LINER MULTIPLE TIMES AGAIN. DR. STILL HAS SUSPICIONS THAT SHE IS DOING IT VOLUNTARILY. CUP, SCREW. LINER AND HEAD WERE REMOVED AND A ZB CUP AND DUAL MOBILITY WAS PLACED WITH A 28+12 SROM HEAD INSERTER INTO ZB DUAL MOBILITY POLY HEAD. CONSTRAINED LINER WAS STILL INTACT AND RING WAS STILL IN CORRECT LOCATION. DON'T HAVE RECORDS FOR THE CUP OR SCREW THAT WAS REMOVED. IT WAS A 50 PINNACLE CUP AND WHAT LOOKED TO BE A 35MM SCREW. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11762610 ↗
• InjuryApr 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED. SURGEON STATED PATIENT WAS SHORT ON OPERATIVE SIDE WHICH PROBABLY LED TO DISLOCATION. HAD TO TAKE OUT THE ACTIS STEM AND PUT IN A COMPETITOR STEM. DOI: (B)(4) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Physical Asymmetry

  MAUDE report 11698198 ↗
• InjuryApr 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD ORIGINAL SURGERY (B)(6) 2021. PATIENT FELL AND HAD A DISLOCATION. REVISED LINER TO CONSTRAINED LINER ON (B)(6) 2021. PATIENT THEN FELL OUT OF BED CAUSING SECOND DISLOCATION. SECOND REVISION COMPLETED TODAY. DOCTOR REMOVED AND RE-IMPLANTED STEM, CONSTRAINED LINER AND HEAD BALL.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 11667235 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED USING DUAL MOBILITY FOR STABILITY. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN - DOR: (B)(4) 2021 (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 11453102 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A DUAL MOBILITY FOR STABILITY. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11436073 ↗
• InjuryDec 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO A DISLOCATED HIP. THE SURGEON EXPLANTED THE CONSTRAINED LINER AND REVISED IT WITH ANOTHER CONSTRAINED LINER. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11040106 ↗