PINNACLE 1217-20-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295009580), received between Dec 20, 2018 and Jun 22, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 25580183 ↗
• InjuryFeb 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE LINER WEAR POST-OP & DEVICE PROTRUDE. PATIENT HAD PAIN ON WALKING. THE PATIENT UNDERWENT TOTAL HIP REPLACEMENT PROCEDURE AT (B)(6) 2020. IN (B)(6) 2025 THE LINER WAS FOUND TO BE WORN, AND THE DEVICES WERE FOUND PROTRUDE. REVISION SURGERY COMPLETED (B)(6) 2025. BOTH THE HEAD AND CUP WERE REPLACED AT REVISION DOI: (B)(6) 2020 DOR: (B)(6) 2025

  Patient problems: Pain

  MAUDE report 21445993 ↗
• InjuryJan 10, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A THA SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, THE CUP STARTED TO COME LOOSE. THEREFORE, A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2025. THE CUP WILL BE REPLACED. ACCORDING TO THE SURGEON, IT WAS NOT A GOOD PROCEDURE TO INSTALL THE CUP IN AN UPRIGHT POSITION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21127232 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS A CASE OF REVISION TOTAL HIP REPLACEMENT ON (B)(6) 2010. THE PRIMARY SURGERY WAS DONE IN (B)(6) 2019 WITH S-ROM STEM, PINNACLE CUP, METAL HEAD, PROXIMAL SLEEVE, ACETABULAR LINER AND REVISED WITH SOLUTION STEM AND METAL HEAD. HIS COBALT CHROME AND CHROMIUM LEVELS ARE GOING UP (ON (B)(6) 2017 - CHROMIUM 5.80 AND COBALT CHROME 1.82 AND ON 22°.2.2019 - CHROMIUM 22.05, COBALT CHROME <2.50). MARS MRI RESULT AWAITED. HE HAS RESTRICTED MOVEMENT WHICH COMPROMISES HIS DAILY ACTIVITIES. HE HAS BEEN ADVISED REVISION TOTAL HIP REPLACEMENT AS EARLY AS POSSIBLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 15249960 ↗
• MalfunctionAug 4, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO TREAT PAIN, BONE LOSS, AND METALLOSIS SECONDARY TO POLYWEAR AND DEBRIS. DOI: (B)(6) 2017, DOR: (B)(6) 2021, UNK HIP.

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

  MAUDE report 12275395 ↗
• InjuryJan 5, 2021Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  (B)(6) YEAR-OLD PATIENT COMES FOR A 15-DAY REVISION OF THE LEFT HIP PROSTHESIS ((B)(6) 2020) FOR HIP DYSPLASIA, WITH A PREVIOUS 5CM SHORTENING, AND IN SURGERY THEY PERFORM A FEMORAL OSTEOTOMY TO REDUCE THE PROSTHESIS. HE REFERS FROM THE IMMEDIATE POST OP TO PRESENTED INTENSE PAIN IN THE LEFT HIP, WHICH DOES NOT IMPROVE WITH ANALGESICS, LIMITS HIS GAIT AND MOVEMENTS OF THE HIP IN TOTAL HIP REPLACEMENT FOR DYSPLASIA, HOSPITALIZED FOR DISLOCATION OF THE HIP PROSTHESIS, CURRENTLY WITH TRACTION OF SOFT TISSUES WITH 3 KG OF WEIGHT, PATIENT WHO IS AFEBRILE, PAINLESS, WITH SHORTENING, ALREADY SCHEDULED FOR SURGERY. ADDITIONAL INFORMATION RECEIVED 12/17/2020: REVISION NOTE STATED THAT THE ACETABULAR COMPONENT HAS MORE THAN 15 DEGREES OF ANTEVERSION AND LOOSE INSERT.

  Patient problems: Adhesion(s); Hematoma; Loss of Range of Motion; Pain; Physical Asymmetry

  MAUDE report 11118271 ↗
• InjuryJun 15, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED 3 YEARS AGO (THE DATE WAS UNKNOWN) VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020 BY REPLACING THE CUP (P/N: UNKNOWN) AND THE INSERT (P/N: UNKNOWN) DUE TO LOOSENING OF IMPLANTS OF CUP SIDE. ACCORDING TO INFECTION¿S EXAMINATION OUTCOME WAS POSITIVE, THERE WAS SUSPICION OF OSTEOLYSIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; No Code Available; Osteolysis; Unspecified Infection

  MAUDE report 10155152 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT BEGUN EXPERIENCING RIGHT THIGH PAIN OVER TIME. HER PAIN WAS LOCALIZED OVER THE DALL-MILES CABLES AND HETEROTOPIC OSSIFICATION AT THE PROXIMAL 1/3 FEMORAL DIAPHYSIS. THE PATIENT PERFORMED A SURGERY ON ((B)(6) 2019) FOR RIGHT FEMUR REMOVAL OF HARDWARE AND EXCISION OF HETEROTOPIC OSSIFICATION. NO OTHER HIP IMPLANTS WERE REVISED. XRAY REPORTED MILD SURROUNDING SOFT TISSUE EDEMA. DOI: (B)(6) 2005; (STEM, SLEEVE, CUP, SCREW), DOI: (B)(6) 2018; (HEAD,LINER), DOR: NONE REPORTED; RIGHT HIP. PLEASE SEE (B)(4) FOR 1ST REVISION OF RIGHT HIP.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9883046 ↗
• InjuryFeb 12, 2020Loss of Osseointegration; Loss of Osseointegration

  PINNACLE CLAIM FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS ADMITTED DUE TO PAIN AND WAS FOUND TO HAD DEVELOPED POST-OP INFECTION. IRRIGATION AND DEBRIDEMENT PLUS IV ANTIBIOTIC TREATMENT DONE ON (B)(6) 2008. SUBSEQUENTLY, REVISION WAS MADE ON (B)(6) 2008. REVISION NOTES REPORTED PURULENCE BETWEEN THE LINER AND SHELL. THE ACETABULUM WAS ALSO FOUND TO BE LOOSE WITHOUT OSTEAL INTEGRATION. THE RIGHT HIP AREA WAS SWOLLEN AND REDDENED. RE-REVISION DONE ON (B)(6) 2009 TO REMOVE THE NON-ARTICULATING ANTIBIOTIC SPACER AND IMPLANTATION OF DEFINITIVE IMPLANTS; NON-DEPUY DEVICES WERE USED. MOREOVER, DURING THE INITIAL HIP REPLACEMENT ON (B)(6) 2007, THE SROM STEM AND SLEEVE WERE TOO TIGHT IN THE BONE SO THE SROM STEM BACKED OUT AND FEMUR OVER REAMED TO 12MM. A CABLE WAS USED TO AVOID INSERTIONAL FRACTURE. IN THIS COURSE, IT RESULTED TO POSTERIOR AVULSION OF THE GREATER TROCHANTER. LATER ON (B)(6) 2007, AN I&D AND EVACUATION OF HEMATOMA WAS DONE AND THE AVULSION WAS REPAIRED. DOI: (B)(6) 2007(CUP, LINER, SLEEVE, SCREWS); DOI: (B)(6) 2008(HEAD, STEM); DOR: (B)(6) 2008; RIGHT HIP.

  Patient problems: Edema; Inadequate Osseointegration; No Code Available; Pain; Unspecified Infection

  MAUDE report 9700104 ↗
• InjuryDec 20, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED PAIN, SWELLING, LACK OF MOBILITY, DAMAGE TO SURROUNDING TISSUE AND BONE CAUSED BY INFLAMMATION, METALLOSIS, PSEUDOTUMOURS, BURSITIS, AND BONE EROSION. UPDATE AD 29 JUN 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP.

  Patient problems: Inadequate Osseointegration; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Swelling; Tissue Damage

  MAUDE report 8183998 ↗