PINNACLE 1218-36-758Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295012160), received between Nov 7, 2018 and Jun 17, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ENTIRE CONSTRUCT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED IN ITS POSITION. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD IMMEDIATELY AND THERE WAS NO HARM DONE TO THE PT. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25540830 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH HEAD AND CONSTRAINED LINER SWAP DUE TO INCREASING GROIN PAIN IN THE PATIENT. THERE WAS NO INDICATION BY THE SURGEON THAT THE IMPLANTS WERE MECHANICALLY FAILING. UPON EXTRACTION OF THE IMPLANTS IT WAS CONFIRMED THAT THEY WERE IN PLACE AS MECHANICALLY DESIGNED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 24005637 ↗
• 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 23630301 ↗
• InjuryJan 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH PINNACLE CONSTRAINED LINER EXCHANGE DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21126734 ↗
• InjuryNov 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INITIAL HIP WAS PERFORMED ABOUT 16 YRS AGO. THE PATIENT WAS REVISED TO A CONSTRAINED LINER ABOUT 10 YRS AGO. PATIENT FELL AND DISLOCATED THE HEAD FROM THE CONSTRAINED LINER. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 18192003 ↗
• InjuryNov 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18119549 ↗
• InjuryAug 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO DISLOCATION. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2023. (RIGHT HIP). TREATMENT: HEAD AND LINER WERE REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 17651369 ↗
• InjuryAug 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO A DISLOCATED HIP. THE SURGEON FOUND IT BEST TO REMOVE THE CONSTRAINED LINER AND METAL FEMORAL HEAD AND REPLACE THEM WITH THE SAME PARTS. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17614142 ↗
• MalfunctionAug 16, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON SWITCHED TO A CONSTRAINED LINER BUT COULD NOT GET THE LOCKING RING TO SEAT, SO HE REMOVED IT AND IMPLANTED ANOTHER ONE. THE SECOND LOCKING RING WOULD NOT SEAT EITHER SO THE RING WAS NOT IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 17558203 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND HIP BECAME UNSTABLE. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOI: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Laxity

  MAUDE report 12173431 ↗
• InjuryJun 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED HER CONSTRAINED LINER WHICH WAS REMOVED. REVISED WITH A COMPETITOR CEMENTED POLY LINER IN HER EXISTING PINNACLE ACETABULAR CUP. FEMORAL STEM WAS NOT REVISED. NO FURTHER INFORMATION. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11931042 ↗
• InjuryApr 15, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATING. DURING THE SURGERY, DR. NOTICED SIGNS OF A POSSIBLE INFECTION AND TOOK CULTURES AND TISSUE SAMPLES TO CHECK. HE THEN DISASSOCIATED THE CONSTRAINED LINER FROM THE CUP WITHOUT USING ANY TOOLS AND SAID THAT THE INNER LOCKING RING ON THE LINER WAS BROKEN. HE THEN CLEANED THE JOINT OUT, PUT IN A NEW CONSTRAINED LINER AND HEAD WITH THE ADDITION OF ANTIBIOTIC BEADS TO THE JOINT SPACE. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 11671977 ↗
• InjuryOct 19, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CONSTRAINED LINER RING BROKEN. LINER AND HEAD REMOVED. NEW LINER/HEAD IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10697367 ↗
• InjuryFeb 5, 2020Fracture; Fracture

  THE PATIENT WAS REVISED TO ADDRESS BROKEN INSERT. HE HAD A LONG SROM STEM WITH A PINNACLE CONSTRAINED INSERT THAT WAS BROKEN. SURGEON REMOVED A BUNCH OF SYNOVIAL TISSUE AND TISSUE THAT LOOKED LIKE IT HAD METAL DEBRIS IN IT. SURGEON STATED AT ONE POINT HE HAD A METAL ON METAL IMPLANT. WE REPLACED CONSTRAINED PINNACLE LINER AND SROM 36 METAL HEAD. DOI: 2014; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9671134 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CONSTRAINED LINER AND CERAMIC HEAD WERE CHANGED DUE TO INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Not Applicable; Unspecified Infection

  MAUDE report 9496881 ↗
• InjurySep 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND IMPLANT RECORDS AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION. DOI: (B)(6) 2013; DOR: (B)(6) 2014, (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9098040 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENTS HIP WAS INFECTED. SURGEON REMOVED THE FEMORAL HEAD AND CONSTRAINED LINER. HE THOROUGHLY WASHED OUT THE HIP, AND THEN REINSERTED A 36 +5 TS CERAMIC HEAD AND 58X36 +4 CONSTRAINED LINER. RAN HIP THROUGH RANGE OF MOTION AND FOUND IT TO BE SATISFACTORY. HE BEGAN THE CLOSING PROCESS. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8804177 ↗
• InjuryMar 26, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON TRIED TO PUT IN A CONSTRAINED LINER, AND THE FIRST ONE HE TRIED HE MESSED UP THE POLY REDUCING THE HIP. HE THEN USED THE SECOND CONSTRAINED LINER AND HE PUT THE LOCKING RING ON BACKWARDS. HE MESSED WITH THAT FOR PROB 30 MIN UNTIL HE REALIZED IT WAS BACKWARDS. I HAD SHOWED HIM THE TEXT GUIDE BEFORE, BUT I COULD NOT GET CLOSE ENOUGH FURRING THE CASE TO SEE HOW HE PUT THE RING ON. HE ENDED UP DAMAGING THE SEVEN LINER THEN HE CHOSE TO IMPLANT A 40 BIPOLAR HEAD IN A 40 LINER. HE FELT IT WAS STABLE AND HE CLOSED. IT WAS FURTHER CLARIFIED THAT THE SURGEON FELT LIKE THE HEAD WAS TOO TALL WHEN HE FIRST TRIED TO REDUCE THE FEMORAL HEAD INTO THE CONSTRAINED LINER. AS HE WAS PULLING REALLY HARD THE FEMORAL HEAD DRAG ACROSS THE LIP OF THE LINER AND DAMAGED IT. AFTER IT WAS DAMAGED FROM THE REDUCTION OF THE FEMORAL HEAD, HE THEN UNREDUCED THE HIP AND TRIED THE BACK UP CONSTRAINED LINER WE HAD. HE USED A SHORTER FEMORAL HEAD TO NOT HURT THE LIP OF THE LINER AS BE REDUCED IT, BUT HE PUT THE CAPTURE RING ON BACKWARDS. HE WAS TRYING FOR AROUND 30 MIN TO GET THE CAPTURE RING ON THE SECOND LINER UNTIL HE FINALLY REALIZED THE RING WAS ON BACKWARDS AND THE BEVELED EDGE W

  Patient problems: Not Applicable

  MAUDE report 8451448 ↗
• InjuryMar 26, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON TRIED TO PUT IN A CONSTRAINED LINER, AND THE FIRST ONE HE TRIED HE MESSED UP THE POLY REDUCING THE HIP. HE THEN USED THE SECOND CONSTRAINED LINER AND HE PUT THE LOCKING RING ON BACKWARDS. HE MESSED WITH THAT FOR PROB 30 MIN UNTIL HE REALIZED IT WAS BACKWARDS. I HAD SHOWED HIM THE TEXT GUIDE BEFORE, BUT I COULD NOT GET CLOSE ENOUGH FURRING THE CASE TO SEE HOW HE PUT THE RING ON. HE ENDED UP DAMAGING THE SEVEN LINER THEN HE CHOSE TO IMPLANT A 40 BIPOLAR HEAD IN A 40 LINER. HE FELT IT WAS STABLE AND HE CLOSED. IT WAS FURTHER CLARIFIED THAT THE SURGEON FELT LIKE THE HEAD WAS TOO TALL WHEN HE FIRST TRIED TO REDUCE THE FEMORAL HEAD INTO THE CONSTRAINED LINER. AS HE WAS PULLING REALLY HARD THE FEMORAL HEAD DRAG ACROSS THE LIP OF THE LINER AND DAMAGED IT. AFTER IT WAS DAMAGED FROM THE REDUCTION OF THE FEMORAL HEAD, HE THEN UNREDUCED THE HIP AND TRIED THE BACK UP CONSTRAINED LINER WE HAD. HE USED A SHORTER FEMORAL HEAD TO NOT HURT THE LIP OF THE LINER AS BE REDUCED IT, BUT HE PUT THE CAPTURE RING ON BACKWARDS. HE WAS TRYING FOR AROUND 30 MIN TO GET THE CAPTURE RING ON THE SECOND LINER UNTIL HE FINALLY REALIZED THE RING WAS ON BACKWARDS AND THE BEVELED EDGE W

  Patient problems: Not Applicable

  MAUDE report 8451440 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8047033 ↗