PINNACLE 1219-28-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295013297), received between Dec 22, 2017 and Feb 26, 2026 — classified as 26 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY AFTER A FALL. THE DEVICE CORAIL/PINNACLE MOP (METAL ON PE) HAD BEEN PREVIOUSLY IMPLANTED ON (B)(6) 2021 ON LEFT SIDE AND DEVICE CORAIL/PINNACLE MOP (METAL ON PE) ON (B)(6) 2022 ON THE RIGHT SIDE AS PART OF THE HIP REPLACEMENT PROCEDURE DUE TO BIONECROSIS OF FEMORAL HEAD. AFTER THE FALL, AN X-RAY PROMPTED REVISION SURGERIES ON BOTH HIPS. FIRST SURGERY TOOK PLACE ON (B)(6) 2026 AND THE SECOND SURGERY TOOK PLACE ON (B)(6) 2026. THERE WAS NO SURGICAL DELAY AND THE CASE WAS COMPLETED WITH PINNACLE ALTRX. THIS REPORT (B)(4). (B)(4) CAPTURE THE LEFT HIP SIDE. (B)(4) CAPTURE THE RIGHT HIP SIDE.

  Patient problems: Fall

  MAUDE report 24461816 ↗
• InjuryAug 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO SURGICAL DELAY.

  Patient problems: Discomfort; Pain

  MAUDE report 19949414 ↗
• InjuryFeb 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP REPLACEMENT. PATIENT WAS DOING DEEP SIDE LUNGES RECENTLY AND AFTERWARDS, FELT SOMETHING NOT RIGHT IN THEIR HIP JOINT. X-RAYS REVEALED A PRESUMPTIVE LINER DISSOCIATION. SURGERY WAS PERFORMED AND IT WAS CONFIRMED THAT THE POLYETHYLENE ACETABULAR LINER HAD DISSOCIATED FROM THE PINNACLE 100 SERIES GRIPTION ACETABULAR SHELL. SURGEON REMOVED THE CERAMIC FEMORAL HEAD AND THE OLD ACETABULAR LINER FROM THE PATIENT. EXAMINED THE INSIDE OF THE SHELL AND DETERMINED THERE WAS NO DAMAGE. SURGEON THEN IMPLANTED A NEW FEMORAL HEAD AND A NEW NEUTRAL MARATHON POLYETHYLENE ACETABULAR LINER IN THE PATIENT. SURGERY FINISHED ACCORDING TO PLAN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 18712195 ↗
• InjuryOct 30, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  THE PATIENT HAD A PRIMARY TOTAL HIP IMPLANTED WITH DEPUY SYNTHES COMPONENTS (CORAIL STEM, PINNACLE SHELL). THE PATIENT INFORMED FAMILY MEMBERS THE SHE WAS EXPERIENCING HIP PAIN AND REVISION TOTAL HIP SURGERY WAS PERFORMED ON THE PATIENT. WHEN THE SURGEON EXPOSED THE JOINT, IT WAS DISCOVERED THAT THE ARTICULEZE HEAD (28 +5), WAS ARTICULATING ON THE INTERIOR OF THE ACETABULAR SHELL. THERE WAS A LARGE HOLE WORN IN THE SHELL (50 SECTOR GRIPTION), AND THE MARATHON POLYETHYLENE LINER (28/50 NEUTRAL), WAS DISSOCIATED FROM THE ACETABULAR SHELL. THE SHELL, LINER AND HEAD WERE THEN EXPLANTED, THE WOUND WAS WASHED OUT THOROUGHLY, ACETABULUM WAS REAMED UP TO 53MM, AND A 54 MULTIHOLE GRIPTION SHELL WAS IMPLANTED, FOLLOWED BY A 54/47 PINNACLE DUAL MOBILITY METAL LINER, A 47/28 PINNACLE BIMENTUM ALTRX HEAD, AND A 28 +1.5MM COCR ARTICULEZE FEMORAL HEAD. THE HIP WAS THEN REDUCED, AND THE WOUND CLOSED UP. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 18028862 ↗
• InjurySep 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INLAY SEEMED TO BE LOOSE. CHANGE INLAY WHICH WAS IMPLANTED IN 2010 AND ALSO CHANGED THE HEAD AS WE EXCHANGED ALL MOBILE COMPONENTS. PATIENT FELL MORE THAN 5 TIMES DURING THOSE YEARS. SOME PEGS OF THE INLAY WERE NOT FULLY SEATED ANYMORE IN THE CUP. DOI: 2010. DOE: (B)(6), 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall

  MAUDE report 17774589 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2005 PATIENT DEVELOPED A DEEP VEIN THROMBOSIS POSTOPERATIVELY. DOI: (B)(6) 2005; DOE: (B)(6) 2005; RIGHT HIP. THIS (B)(4) IS A LINK OF (B)(4).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17070110 ↗
• InjuryApr 21, 2023Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS PAIN. THE STEM WAS ALSO FRACTURED AND HAD TO BE REMOVED WELL INGROWN SLEEVE AND DISTAL ASPECT OF THE FRACTURED STEM. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Distress; Pain

  MAUDE report 16787922 ↗
• InjuryJan 24, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  PATIENT WAS REVISED FOR A DISASSOCIATION PINNACLE POLYETHYLENE LINER. THERE WAS LOOSENING OF DISASSOCIATED POLY LINER AT THE NON-CEMENTED INTERFACE. UPON RETRIEVAL THE LINER HAD 3 BROKEN ARDS AND HAD SHOWN SIGNS OF WARPINGS. PATIENT STATED THAT SHE HAD SUSTAINED A FALL. THE SCREW HEAD OF THE DOME SCREW WAS DETERMINED TO BE APPROPRIATELY SEATED AND NOT A POTENTIAL CAUSE FOR LINER FAILURE. AS THE PATIENT WAS CONCERNED ABOUT THE REASON FOR THE LINER FAILURE THE DECISION WAS MADE TO EXPLANT THE CUP AND REVISE TO A COMPETITOR'S (SMITH AND NEPHEW) CUP AND LINER. THE EXISTING METAL HEAD WAS EXPLANTED AND REPLATED WITH A DEPUY 36+8.5 BIOLOX TS HEAD AS THE TRILOCK BPS STEM WAS WELL FIXED AND RETAINED. NO SURGICAL DELAY. DOI: 2009, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall

  MAUDE report 16231885 ↗
• InjuryOct 17, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE PATIENT RECEIVED A TOTAL HIP REPLACEMENT IN 2018. IN SPRING OF 2022 THE PATIENT FELT A STRANGE SENSATION WHEN GETTING ONTO A MOTORCYCLE. NOTHING UNUSUAL WAS FELT BY THE PATIENT DURING THE REST OF THE SPRING AND SUMMER 2022. IN THE PAST WEEK THE PATIENT FELT SOMETHING UNUSUAL WITH HER HIP AND IT DID NOT FEEL RIGHT. SHE KNEW SOMETHING WAS WRONG AND WENT TO THE HOSPITAL. X-RAYS REVEALED WHAT APPEARED TO BE A DISASSOCIATED ACETABULAR LINER, AS THE 28MM +1.5 CERAMIC FEMORAL HEAD (136528310) APPEARED TO BE RESTING AGAINST THE SUPERIOR WALL OF THE INSIDE OF THE ACETABULAR SHELL. PATIENT UNDERWENT REVISION SURGERY TODAY (B)(6) 2022) AND IT WAS CONFIRMED THAT THE PINNACLE MARATHON NEUTRAL LINER HAD DISASSOCIATED FROM THE SHELL PINNACLE SECTOR GRIPTION ACETABULAR SHELL. THE SURGEON PROCEEDED TO REMOVE THE CERAMIC FEMORAL HEAD AND THEN REMOVE THE DISASSOCIATED MARATHON LINER, AND INSPECT THE INSIDE OF THE ACETABULAR SHELL FOR ANY DAMAGE AND ALSO THE SURGERY PROCEEDED TO INSPECT THE TRUNION OF THE CORAIL FEMORAL STEM FOR ANY DAMAGE. UPON CAREFUL INSPECTION, THE SURGEON DETERMINED THAT NO DAMAGE HAD OCCURRED TO EITHER THE INSIDE OF THE ACETABULAR SHELL OR THE TRUNION OF THE FEMORAL STEM. IT

  Patient problems: Discomfort

  MAUDE report 15614367 ↗
• InjuryJan 21, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF POLY AND HEAD, NATURAL PROGRESSION. DOI: (B)(6) 2008, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 13313874 ↗
• InjurySep 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS DISLOCATIONS OF ACETABULAR LINER AND FEMORAL HEAD. NO SURGICAL DELAY. DOI: (B)(6) 2004, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12440541 ↗
• InjuryJan 4, 2021Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  INLAY DISLOCATION WITH CERAMIC HEAD FRACTURE OF HIP TEP LEFT SIDE WITH NECESSARY REVISION SURGERY ON (B)(6) 2020. INITIAL IMPLANTATION OF THE CEMENTLESS HIP REPLACEMENT ON (B)(6) 2014.

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

  MAUDE report 11107835 ↗
• InjuryAug 5, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  TODAY I COVERED A REVISION HIP , PATIENT HAD A TOTAL HIP REPLACEMENT DONE (B)(6) 2017. PATIENT HAD A CORAIL STEM WITH PINNACLE 100SERIOUS CUP WITH A 28 MM /50 MM NEUTRAL LINER. PATIENT NEEDED THE CUP AND LINER REVISION, CONSULT (SURGEON) REQUEST WE REVIEW THE LINER AS THE LOCKING MECHANISM APPEARED TO HAVE FAILED IN THE PATIENT. PATIENT AT THE TIME HAS A BMI OF OVER 56 BUT HAS SINCE LOST LOADS OF WEIGHT.

  Patient problems: Foreign Body Reaction; No Code Available; Pain

  MAUDE report 10367638 ↗
• InjuryFeb 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESSED INSTABILITY. OPERATIVE NOTES INDICATED RECURRENT DISLOCATION. UPON INCISION THROUGH SKIN AND SUBCUTANEOUS TISSUE TO THE FASCIA LATA, A LARGE AMOUNT OF CLEAR FLUID WAS EXPRESSED ALMOST UNDER PRESSURE OUT OF THE HIP JOINT. A MODERATE LARGE AMOUNT CHEESY GRANULOMATOUS TYPE MATERIAL IN THE HIP JOINT. ATTENTION WAS ON CUP, CUP WAS NOTED THAT APPEARED TO BE ANTEVERTED MORE THAN USUAL, ALTHOUGH THE CUP ITSELF WAS SMOOTH POSTERIORLY IN TERMS HOWEVER NO FRACTURE WAS INVOLVE. CUP WAS REMOVE WITH ONLY A SMALL AMOUNT OF BONE ATTACHED. DOI: (B)(6) 2004 (LINER & HEAD). DOI: (B)(6) 2002 (CUP). DOR: (B)(6) 2006 RIGHT HIP 2ND REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9717540 ↗
• InjuryJul 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE TO FEMORAL STEM AND DISLOCATION. THE ORIGINAL IMPLANT DATE IS UNKNOWN. DUE TO AGE AND DISLOCATION, THE SURGEON CHANGED OUT PINNACLE LINER FROM NEUTRAL 28X50MM TO A CONSTRAINED 28 X 50MM +4 NEUTRAL. THE FEMORAL STEM AND PREVIOUS CABLES MANUFACTURER IS UNKNOWN. THE SURGEON IMPLANTED A PROXIMAL FEMORAL REPLACEMENT FROM LINK ORTHOPAEDICS WITH LINK 28MM FEMORAL HEAD. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8812838 ↗
• InjuryMay 30, 2019Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn; Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE AFFECTED SIDE IS LEFT HIP. IT WAS STATED THAT THE INLAY WAS DISLOCATED WITH THE CUP BEING FIRMLY ATTACHED. THE LATERAL FASTENING OF THE INLAY WAS COMPLETELY BROKEN OFF IN THREE LOCATIONS AND CLEARLY WORN IN THREE LOCATIONS. THE INLAY ITSELF SHOWS DEEP ABRASION MARKS ON THE OUTSIDE.

  Patient problems: Fall; Joint Disorder; No Code Available

  MAUDE report 8653571 ↗
• InjuryMay 14, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT PRESENT TO THE SURGEON WITH PAIN IN HER LEFT HIP, XRAY'S SHOWED THAT THE PINNACLE LINER HAD DISASSOCIATED FROM THE PINNACLE CUP. SURGEON REMOVED HEAD AND LOOSE LINER. A NEW LINER AND HEAD WAS PLACED IN PATIENT. DOI: (B)(6) 2012; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8609177 ↗
• InjuryApr 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO PAIN CAUSED BY LINER THAT HAD DISASSOCIATED FROM CUP. DOI: (B)(6) 2012; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8479405 ↗
• InjuryMar 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION, METALLOSIS, ELEVATED METAL IONS AND METAL WEAR. DOI: (B)(6) 2007; DOR: (B)(6) 2007; (LEFT HIP). THIS PC IS FOR THE FIRST REVISION OF THE LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available; Tissue Damage

  MAUDE report 8428858 ↗
• InjuryFeb 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF HIP INLAY AND HEAD BECAUSE OF PE-WEAR. THE INLAY IS WORN ON THE INFERIOR ASPECT. LUXATION OCCURRED AND A REVISION WAS DONE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8309798 ↗
• InjuryJan 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REVISED DUE TO DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8270362 ↗
• InjuryOct 24, 2018Biocompatibility; Biocompatibility

  LITIGATION PAPERS ALLEGE THE PATIENT WAS EXPOSED TO SUSTAINED HIGH LEVELS OF METAL IONS. UPDATE: 3/7/2012. DOI: (B)(6) 2008 (LEFT HIP). UPDATE AD 1 MAY 2018: RECEIPT OF PPF AND STICKER SHEETS. THERE WERE NO NEW ALLEGATIONS REPORTED. ADDED LINER TO THE IMPACTED PRODUCTS, ADDED LAWYER TO ASSOCIATED CONTACTS AND LAW FIRM. UPDATED PATIENT'S INITIALS.

  Patient problems: Test Result

  MAUDE report 7999190 ↗
• InjuryJul 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED IN RECOVERY, ALL PRODUCTS WERE REMOVED WHEN THE PATIENT RETURNED TO OR ON THE SAME EVENING. THE PATIENT WAS REVISED AND DID WELL WITH SROM AND CUP FROM COMPETITOR. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7691372 ↗
• InjuryApr 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ORIGINAL SURGERY 2003. RIGHT HIP REVISION. PATIENT FREQUENTLY DISLOCATED, REMOVED HOLE ELMINATOR, HEAD AND LINER. REPLACED WITH CONSTRAINED LINER AND LONGER HEAD. NO SURGICAL DELAYS. NO BROKEN INSTRUMENTS PATIENT CONSEQUENCE?: UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7471992 ↗
• InjuryFeb 13, 2018Disassembly; Fracture; Naturally Worn; Disassembly; Fracture; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS POLY WEAR OF ACETABULAR LINER. IT WAS ALSO INDICATED THAT LOCKING TABS SHEARED OFF RESULTING IN POLY SPIN OUT. DOI: 2011; DOR: (B)(6) 2018; RIGHT HIP. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7266264 ↗