PINNACLE GRIPTION 1217-30-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295009955), received between Mar 13, 2019 and Nov 20, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Use of Device Problem; Use of Device Problem

  THIS PATIENT HAS A SROM PINNACLE CONSTRUCT IMPLANTED SOMETIME AGO. THE ORIGINAL DATE OF SURGERY IS UNKNOWN. THE PATIENT WAS DOING WELL YEARS AFTER THE SURGERY UNTIL RECENTLY WHERE PATIENT BECAME UNSTABLE AND DISLOCATED. SEVERAL CLOSED REDUCTIONS WERE DONE OVER THE PAST YEAR. AS THEY BECAME MORE FREQUENT, THE DECISION WAS MADE TO REVISE THE PATIENTS CONSTRUCT. DOCTOR EXPLANTED THE PATIENTS PINNACLE ACETABULAR CUP, LINER, AND SROM FEMORAL HIP BALL. THE SROM STEM AND SLEEVE WERE LEFT IN SITU. DOCTOR STATED THAT THE ACETABULAR CUP ABDUCTION ANGLE WAS TOO VERTICAL WHICH CONTRIBUTED TO THE DISLOCATION ISSUE. A NEW ACETABULAR CUP AND FEMORAL HIP BALL WERE IMPLANTED PROVIDING SATISFACTORY STABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23606687 ↗
• InjuryMay 17, 2025Improper or Incorrect Procedure or Method; Osseointegration Problem; Improper or Incorrect Procedure or Method; Osseointegration Problem

  IT WAS REPORTED THAT THE PINNACLE CUP, LINER, AND DELTA CERAMIC HEAD WERE REMOVED DUE TO ASEPTIC LOOSENING OF PINNACLE GRIPTION MULTIHOLE. IT WAS NOTED THE CUP WAS UNDERSIZED AND LOOSE AT THE CUP/ACETABULAR INTERFACE. THE IMPLANTS WERE REPLACED AND NO SURGICAL DELAY WAS NOTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22041145 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19044242 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL CASE IN REGARDS TO (B)(4) TO CAPTURE THE PREVIOUS REVISION. THE PATIENT RETURNED FOR PINNACLE CUP SIZE INCREASE AND PUT IN A CONSTRAINED LINER.

  Patient problems: Unspecified Infection

  MAUDE report 18721330 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17097705 ↗
• InjuryNov 17, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO INFECTED HIP. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. THE ACETABULAR CUP WAS LOOSE. LOOSENING INTERFACE WAS NON-CEMENTED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 15819922 ↗
• InjuryNov 2, 2022Use of Device Problem; Osseointegration Problem; Use of Device Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA WITH THE PINNACLE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE LOOSENING OF THE IMPLANTS ON THE ACETABULUM SIDE WAS CONFIRMED ON AU UNKNOWN DATE. THE STEM IS NOT LOOSE. THE CUP WAS INSERTED STANDING UP BECAUSE THE OUTWARD OPENING ANGLE WAS SMALL AT THE TIME OF PRIMARY SURGERY. THE REVISION OF THE CUP, SCREW, LINER AND HEAD IMPLANTS HAPPENED (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2016. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15713674 ↗
• InjuryOct 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO THE LINER DISASSOCIATED FROM CUP. NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT.

  Patient problems: Joint Dislocation

  MAUDE report 15588394 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID A THA IN THIS PATIENT APPROXIMATELY A YEAR AND A HALF AGO ACCORDING TO THE DOCTOR. THIS PATIENT DID FINE INITIALLY BUT HAS DISLOCATED SEVERAL TIMES OVER THE LAST FEW MONTHS. THE SURGEON AND THE PATIENT DECIDED TO DO A REVISION ON THE HIP TO ACHIEVE GREATER STABILITY. THE 46MM ACETABULAR CUP , 28MM + 5 HIP BALL, 25MM SCREW, 46 ALTRX LINER WERE EXPLANTED AND REPLACED WITH A 50MM ACETABULAR CUP WHERE SURGEON HAD A CONSTRAINED LINER OPTION TO PROVIDE OPTIMAL STABILITY. I DO NOT HAVE ADDITIONAL INFORMATION TO SHARE AT THIS TIME. DOI: APPROXIMATELY A YEAR AND A HALF AGO, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15241275 ↗
• InjurySep 22, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PT. FELL AND FRACTURED THE PROXIMAL FEMUR. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AND CUP AT THE BONE TO IMPLANT INTERFACE. THE STEM WAS LOOSE BUT DURING THE CASE, THEY DISCOVERED THAT THE CUP WAS ALSO LOOSE. HE REVISED BOTH GOING TO A 48 CUP AND CORAIL REVISION STEM. EVERYTHING WAS STABLE FOLLOWING THE REVISION. DOI: (B)(6) 2021, DOR: (B)(6)2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 12512894 ↗
• InjurySep 28, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT IMPLANTS WERE RECEIVED WITH AN ALLEGATION OF IMPLANT FRACTURE OF POLYETHYLENE LINER AND WEARING OF THE ACETABULAR CUP. DOI: UNKNOWN, DOR: UNKNOWN, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 10593456 ↗
• InjuryAug 14, 2020Noise, Audible; Noise, Audible

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2016 VIA THA. IT WAS REPORTED THAT IMPINGEMENT NOISE BETWEEN THE CUP AND THE HEAD WAS FOUND WHEN THE PATIENT VISITED THE HOSPITAL. THE SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2020 DUE TO SUSPICION OF LINER¿S DISLOCATION AND THE CUP AND THE HEAD¿S IMPINGEMENT. DURING THE REVISION SURGERY, THE SURGEON CONFIRMED THE DISLOCATION OF THE LINER, AND THE CUP IMPINGED THE HEAD. METALLOSIS WAS FOUND TOGETHER. THE SURGEON REMOVED THE SCREW AND REPLACED THE LINER AND THE HEAD. HE REMAINED THE CUP BECAUSE THERE WAS NO LOOSENING OF THE CUP AND HE WANT MINIMALLY INVASIVE SURGERY FOR THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT CAUSE OF DISLOCATION WAS UNKNOWN. HE DOUBTED THAT THE DISLOCATION THOUGHT TO BE DUE TO THE PATIENT¿S FALLING AND THE SCREWHEAD¿S SLIGHTLY PROTRUDING. ONLY FALLING AND SCREW¿S PROTRUDING CAUSED THE DISLOCATION? NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Joint Disorder; No Code Available

  MAUDE report 10408547 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10188414 ↗
• InjuryMar 30, 2020Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE CUP WAS IMPLANTED ON (B)(6) 2013. THE LINER AND HEAD WERE IMPLANTED ON (B)(6) 2019. YESTERDAY WE REMOVED THE CUP, HEAD, AND LINER. THE HEAD AND LINER LOOKED PERFECT BUT THE SHELL HAD A HOLE WORN ALL THE WAY THROUGH. THE HOLE WAS BETWEEN 1/2¿-3/4¿ IN SIZE. THEY WEREN'T ABLE TO REMOVE THE STEM SO WE IMPLANTED A BIPOLAR HEAD INSTEAD OF USING A PROSTALAC STEM FOR A STAGE 1 REVISION. DOI: (B)(6) 2013, (CUP). DOI: (B)(6) 2019, (LINER AND HEAD). DOR: (B)(6) 2020, AFFECTED SITE: UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 9899234 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION OF THE LEFT HIP. SURGEON EXPLANTED PINNACLE CUP, LINER AND STEM REVISING WITH COMPETITIVE MDM. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9727686 ↗
• InjuryJan 7, 2020Use of Device Problem; Loss of Osseointegration; Malposition of Device; Osseointegration Problem; Use of Device Problem; Loss of Osseointegration; Malposition of Device; Osseointegration Problem

  IT WAS REPORTED THAT THE PINNACLE CUP SEEMED TO MOVE IN A VERTICAL POSITION AND WAS LOOSENED AT BONE TO IMPLANT INTERFACE. THE SURGEON DECIDED TO REMOVE THE CUP AND PLACE ANOTHER IN THE PROPER POSITION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9558462 ↗
• InjuryNov 27, 2019Loss of Osseointegration; Osseointegration Problem; Unintended Movement; Migration; Loss of Osseointegration; Osseointegration Problem; Unintended Movement; Migration

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE IS UNKNOWN. DOCTOR SAID PATIENT HIP WAS DISLOCATED DUE TO THE CUP COMING DISLODGED FROM ACETABULUM. IT WAS INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. HE REMOVED THE ACETABULAR COMPONENTS AND FEMORAL HEAD FROM THE TRILOCK STEM. THE STEM WAS WELL FIXED, SO HE WANTED TO LEAVE THAT. HE REVISED THE CUP WITH A COMPETITOR MULTIHOLE COMPONENT. DOI: UNKNOWN. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9383684 ↗
• InjuryJul 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE LEGAL CLAIM AND MEDICAL RECORDS RECEIVED. IT WAS REPORTED THAT THE PATIENT'S POLY LINER WAS DEFECTIVE. AFTER REVIEW OF MEDICAL RECORDS, THERE WAS NO REVISION REPORTED. NO KNOWN PATIENT CONSEQUENCE. DOI: (B)(6) 2015, DOR: (B)(6) 2017, (RIGHT HIP).

  Patient problems: Anxiety; Depression; Foreign Body Reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 8773384 ↗
• InjuryJun 21, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT CUP WAS MALPOSITIONED AND SHE WAS HAVING IMPINGEMENT PROBLEMS. HE DECIDED TO REMOVE THE CUP LINER AND HEAD. HE REAMED UP THE ACETABULUM TO A SIZE 52, AND RE-IMPLANT A NEW CUP LINER AND HEAD. NO ONE INDICATED A PROBLEM WITH IMPLANTS. DOI: (B)(6) 2017, DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 8724018 ↗
• InjuryMay 17, 2019Loss of Osseointegration; Loss of Osseointegration

  ON (B)(6) 2017: LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES DISCOMFORT, PAIN, STIFFNESS, LOSS OF MOTION, IMPLANT LOOSENING, TISSUE DAMAGE AND MUSCLE DAMAGE. UPDATE AUG 29, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES DISLOCATION, INSTABILITY, WEIGHT-BEARING LIMITATION, LEG LENGTH DISCREPANCY, AMBULATION DIFFICULTIES, AND SCOLIOSIS. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS FAILED UNSTABLE LEFT THA. REVISION NOTES STATED THAT THE HIP WAS COMPLETELY UNSTABLE AND THE STEM WAS SLIGHTLY ANTEVERTED. THE PATIENT WAS COMPLETELY REVISED FROM PINNACLE TO SROM CONSTRUCT. PRODUCT INFORMATION IS UPDATED. ADDING CUP, HOLE ELIMINATOR, AND 2 SCREWS. THIS COMPLAINT WAS UPDATED ON SEP 18, 2017. UPDATE 8/29/2017 MEDICAL RECORDS WERE REVIEWED. DETERMINED THAT DATE OF THE FIRST OPEN REVISION WAS APR 6, 2016 (PRIOR SURGERIES WERE CLOSED REDUCTIONS). OPERATIVE RECORD FOR APR 6, 2016 INDICATED NO EVIDENCE OF IMPLANT LOOSENING IN CONTRAST TO WHAT WAS ALLEGED. SURGEON STATED THAT ALTHOUGH THE STEM WAS SLIGHTLY ANTEVERTED, IT WAS NOT SUFFICIENT ENOUGH TO ADDRESS THE DISLOCATION ISSU

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Muscular Rigidity; No Code Available; Pain; Tissue Damage

  MAUDE report 8619168 ↗
• InjuryApr 25, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE BROKEN CUP (P/N: 121730046), THE LINER (P/N: 122428146), THE HEAD (P/N: 136528110) AND REMOVING PSEUDOTUMOR DUE TO PSEUDOTUMOR CAUSED BY ARMD THAT SEEMED TO BE CAUSED BY POSTOPERATIVE DISLOCATION. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8551107 ↗
• InjuryMar 13, 2019Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING/PROTRUSION OF ACETABULAR COMPONENT AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2016; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; No Code Available

  MAUDE report 8417392 ↗