PINNACLE POROCOAT 1217-03-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10603295008651), received between Jul 11, 2017 and Jul 25, 2025 — classified as 55 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN (B)(6) 2012, THE PATIENT UNDERWENT A THA SURGERY WITH THE IMPLANT IN QUESTION. AFTER THE SURGERY ON AN UNKNOWN DATE, THE PATIENT WAS IN PAIN AND HAS HAD CLEANING DONE AT HOSPITAL, DUE TO THE INFECTION. HOWEVER, THE INFECTION HAS NOT SUBSIDED, SO ON (B)(6) 2025, ALL IMPLANTS IN THE PATIENT'S BODY WERE REMOVED. REOPERATION IS SCHEDULED FOR ABOUT 6-8 WEEKS LATER, WHEN THE CRP LEVEL RETURNS TO NORMAL. THE SURGEON COMMENTED THAT THE CONDITION OF THE PATIENT'S SKIN WAS NOT GOOD TO BEGIN WITH, AND THAT THE PROBLEM WAS NOT WITH THE IMPLANTS THEMSELVES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22613799 ↗
• InjuryJul 9, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Insufficient Information

  MAUDE report 19702737 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2004 DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18837255 ↗
• InjuryMar 16, 2023Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem

  AFTER REVIEW OF THE MEDICAL RECORD, REVISION NOTES STATED THAT FLUID WAS TAKEN FROM THE HIP AND SENT FOR SPECIMEN, AND REMOVED FURTHER SYNOVIAL FLUID. CUP, LINER, AND HEAD WERE REMOVED DURING REVISION AND THE LINER WAS POSSIBLY DISLODGED IT WAS NOT SEATED COMPLETELY WITHIN THE ACETABULAR COMPONENT.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16551487 ↗
• InjuryJan 25, 2023Use of Device Problem; Osseointegration Problem; Use of Device Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PINNACLE CUP WAS MISPOSITIONED AND LOOSE. ITEMS WERE REMOVED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16239623 ↗
• InjuryJan 12, 2023Corroded; Corroded

  MEDICAL RECORDS WERE RECEIVED AND STATED THE FOLLOWING: LITIGATION ALLEGES METALLOSIS, ELEVATED METAL IONS, ADVERSE LOCAL TISSUE REACTION, PSEUDOTUMOR, PAIN, STIFFNESS, CARDIOMYOPATHY, LOSS OF MOTION IN BOTH HIPS, SUFFERING AND EMOTIONAL DISTRESS. DOI:(B)(6) 2002; DOR: (B)(6) 2021 ; RIGHT HIP.

  Patient problems: Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 16146625 ↗
• InjuryJan 12, 2023Corroded; Corroded

  IT WAS REPORTED THAT PINNACLE METAL ON METAL REVISED TO CERAMIC OR POLY. REVISED DUE TO ELEVATED COBALT IONS LEVELS (17) AND METALLOSIS. NO EVIDENCE OF PSEUDOTUMOR. CORROSION ON THE TRUNNION. DOI: (B)(6) 2003. DOR: (B)(6). AFFECTED SIDE: UNKNOWN.

  Patient problems: Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 16146235 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY WITH THE CUP IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT HAS AN INFECTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15974022 ↗
• InjuryNov 8, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED PATIENT HAD PRIMARY ACETABULAR CUP REMOVED DURING REVISION DUE TO PRIOR DISLOCATION AND REPLACED WITH BIOMET REVISION CUP AND NEW FEMORAL HEAD. SURGEON ELECTED TO REMOVE PRIMARY CUP AND CHANGE ITS POSITION SLIGHTLY. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 15755000 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED HIP. REMOVED ALL IMPLANTS. THERE WAS NO REPORTED LOOSENING. IT WAS UNKNOWN IF ANY SURGICAL DELAY OCCURRED. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15391415 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO ACTIVE INFECTION. SURGEON MADE THE DECISION TO REMOVE ALL IMPLANTS AND IMPLANT ANTIBIOTIC SPACERS. DOI: (B)(6) 2021, DOE: (B)(6) 2022, AFFECTED SIDE: UNK.

  Patient problems: Unspecified Infection

  MAUDE report 13997689 ↗
• InjuryAug 18, 2021Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  PATIENT PRESENTED TO HCP APPROXIMATELY 4 MONTHS POST-OPERATIVELY OF HER PRIMARY HIP REPLACEMENT AFTER SHE FELT SOMETHING 'GIVE' IN HER HIP. SHE IMMEDIATELY DETECTED A SQUEAK IN HER HIP INDICATING SOMETHING HAD CHANGED. SHE HAD NO PAIN AND WALKED NORMALLY. SHE HAS IN A METAL ON POLYETHYLENE BEARING, SO SQUEAK IS NOT EXPECTED. THE SURGEON SUSPECTED THE ACETABULAR LINER MAY HAVE DISLODGED FROM THE SHELL. THIS WAS FROM RADIOGRAPHIC ANALYSIS. PATIENT WAS TAKEN TO THEATRE TODAY (WITHIN 24HRS) AND WHEN OPENED, IT WAS CONFIRMED THAT THE ACETABULAR LINER WAS DISLODGED FROM THE PINNACLE SHELL. THE SQUEAK WAS DEEMED TO HAVE BEEN THE METAL HEAD RUBBING ON THE INSIDE OF THE PINNACLE SHELL WHERE THE DISLODGED LINER SHOULD HAVE BEEN. A NEW REPLACEMENT LINER AND FEMORAL HEAD WERE INSERTED, HIP REDUCED AND ROUTINE CLOSURE. THE SURGEON IS CONFIDENT ALL WILL BE WELL. THE CONCERN WAS WHY THE LINER DISENGAGED FROM THE SHELL. THERE WERE ALSO 2 MISSING LUGS ON THE PERIPHERY OF THE LINER. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REVISION. IN ADDITION TO WHAT HAS BEEN PREVIOUSLY REPORTED, THE PATIENT ALSO EXPERIENCED A 4-8MM LEG LENGTH DISCREPANCY PRE-REVISION AN

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Physical Asymmetry

  MAUDE report 12337410 ↗
• InjuryJul 15, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION ACETABULAR SURGERY DUE TO DISLOCATION. POLY WAS FOUND TO HAVE DISASSOCIATED FROM ACETABULAR CUP RESULTING IN WEAR TO ACETABULAR CUP AND METALLOSIS IN ACETABULAR REGION. ACETABULAR PRIMARY CUP WAS REPLACED WITH A PINNACLE SECTOR 56 CUP AND 40 X 56 NEUTRAL POLY AND 40MM +5 FEMORAL HEAD. IT ALSO INDICATED IN DER THAT THERE WAS LOOSENING TO A POLY COMPONENT WITH UNKNOWN INTERFACE. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT HIP.

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

  MAUDE report 12173754 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A TOTAL HIP ON (B)(6) 2017. HE RECENTLY COMPLAINED OF HIP PAIN. X-RAYS LOOKED LIKE THE STEM IS LOOSE. HE HAD REVISION SURGERY ON (B)(6) 2020 AND TISSUE CULTURES REVEALED THE HIP WAS INFECTED. SO THE SURGEON REMOVED ALL IMPLANTS. DOI: (B)(6) 2017: DOR: (B)(6) 2020; RIGHT HIP.

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

  MAUDE report 11089777 ↗
• InjuryOct 27, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S MEDIAL WALL GAVE IN AND THE 300 SERIES CUP ENTERED THE PELVIC CAVITY. IT WAS REVISED AND REPAIRED. DOI: (B)(6) 2020. DOR: (B)(6) 2020; UNKNOWN HIP.

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

  MAUDE report 10740758 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISE TO ADDRESS PAIN. DOI: (B)(6) 2007. DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10137650 ↗
• InjuryMay 26, 2020Fracture; Malposition of Device; Device Dislodged or Dislocated; Fracture; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A FAILED PINNACLE LINER. THE CUP WAS POORLY POSITIONED AND THE SUPERIOR ASPECT OF THE POLY BROKE. THE HEAD THEN ARTICULATED WITH THE SHELL AND WORE MUCH OF THE TITANIUM ON THE SHELL AWAY. WE REMOVED THE HEAD, LINER AND SHELL AND REPLACED WITH NEW IMPLANTS. DOI: 6 YEARS AGO. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10088537 ↗
• InjuryApr 2, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION PAPERS ALLEGE THE PATIENT WAS REVISED DUE TO IMPLANT FAILURE. UPDATE REC'D 5/12/2014 - AMENDED LITIGATION PAPERS RECEIVED. ORIGINAL LITIGATION INDICATED THAT THE PATIENT WAS IMPLANTED WITH ASR; HOWEVER, AMENDED LITIGATION ALLEGES THAT THE PATIENT WAS IMPLANTED WITH PINNACLE. THE PRODUCTS HAVE BEEN UPDATED AND FOLLOW-UPS CREATED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM DAMAGE TO HER HIP JOINTS AND BODY. A DOI HAS BEEN PROVIDED AND LITIGATION INDICATED IT IS FOR THE LEFT HIP. UPDATE - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PART/LOT NUMBERS WERE UPDATED. LITIGATION PAPERS ALLEGE THE PATIENT HAD PAIN AND A LUMP AND THAT "THE TOP OF IMPLANT NEEDS REPLACED". AT THE TIME OF THIS REVIEW THERE WAS NO MENTION OF LUMPS OR NEED FOR REVISION IN THE MEDICAL DOCUMENTS PROVIDED AND NO REVISIONS LISTED. THE COMPLAINT WAS UPDATED ON:(B)(6) 2015. UPDATE 6/30/2016 - PATIENT WAS REVISED DUE TO PAIN. REMOVED HEAD AND LINER. THERE IS NO NEW INFORMATION THAT WOULD AFFECT TH

  Patient problems: Burning Sensation; Edema; Foreign Body Reaction; No Code Available; Pain

  MAUDE report 9916077 ↗
• InjuryMar 20, 2020Malposition of Device; Malposition of Device

  LITIGATION ALLEGES THAT PATIENT SUFFERED FROM SEVERE PAIN AND DISCOMFORT IN HIS LEFT HIP. THE PAIN HAS BEEN CONTINUOUS AND HAS SIGNIFICANTLY INTERFERED WITH HIS NORMAL DAILY ACTIVITIES. DOI: (B)(6) 2006. DOR: (B)(6) 2010; (RIGHT HIP). PART/ LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE IF NEEDED FOR FURTHER REVIEW. MEDICAL RECORDS CONFIRM THE PRODUCT PLACEMENT IN THE RIGHT HIP. UPDATE AD 20 JUN 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. PPF HAS NO NEW ALLEGATION. ADDED FACILITY NAME, LAWYER, PRODUCTS EXPIRATION AND UDI. DOI: (B)(6) 2006. DOR: (B)(6) 2010; (RIGHT HIP). PATIENT IS BILATERAL, PLEASE SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Discomfort; Edema; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage

  MAUDE report 9860317 ↗
• InjuryMar 9, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT'S MOST RECENT COMPLAINTS ARE OF PAIN IN THE FEELING OF CLICKING AND SUBLUXATING WITHIN THE RIGHT JOINT. X-RAYS DEMONSTRATED ACETABULAR COMPONENT AT APPROXIMATELY 75 DEGREES OF ABDUCTION AND RETROVERTED. PROXIMAL FEMORAL GREATER TROCHANTERIC BONY LYSIS WAS EVIDENT BUT FEMORAL COMPONENT APPEARED TO BE WELL INTACT. METAL IONS DEMONSTRATED A COBALT LEVEL OF 111 AND CHROMIUM OF 37. MRI DEMONSTRATED A PERIACETABULAR FLUID COLLECTION WITH EXTENSION BOTH ANTERIOR AND LATERAL. PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT TOTAL HIP ARTHROPLASTY, METALLOSIS RIGHT TOTAL HIP ARTHROPLASTY, ABDUCTOR TEAR RIGHT HIP SECONDARY TO METALLOSIS, AND PROXIMAL FEMORAL BONY LYSIS SECONDARY TO METALLOSIS. OPERATIVE FINDINGS STATED THAT THE FEMORAL COMPONENT DEMONSTRATED TO BE IN NEUTRAL ANTEVERSION BUT VERY WELL FIXED. SIGNIFICANT PROXIMAL GREATER TROCHANTERIC OSTIAL LYSIS SECONDARY TO METALLOSIS WAS APPRECIATED. METALLOSIS CONSISTED OF AN AREA IN THE GREATER TROCHANTER THAT EXTENDED DOWN APPROXIMATELY 4 CM ESPECIALLY LATERALLY ALONG THE FEMUR. COMMINUTION OF THE MOST PROXIMAL 2-3 CM OF THE GREATER TROCHANTER WAS FOUND SECONDARY TO METALLOSIS, THIS HAS TO BE CONSIDER

  Patient problems: Adhesion(s); Edema; Foreign Body Reaction; No Code Available; Osteolysis; Pain; Tissue Damage

  MAUDE report 9805876 ↗
• InjuryFeb 21, 2020Malposition of Device; Malposition of Device

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT COMPLAINS OF WORSENING RIGHT HIP AND GROIN PAIN AND HAD INCREASED METAL IONS, AS WELL AS CROSS-TABLE LATERAL OF THE PELVIS SHOWING INCREASED ANTEVERSION POTENTIALLY LEADING TO EDGE LOADING. THE PATIENT WAS THEN REVISED FOR RIGHT METAL ON METAL TOTAL HIP. TOTAL HIP ARTHROPLASTY WITH ELEVATED METAL IONS. OPERATIVE NOTES REPORTED THAT THERE WAS NOTED TO BE METALLOSIS AROUND THE SURROUNDING SOFT TISSUES EVEN PRIOR TO ENTERING IN THE CAPSULE. THERE WAS NOTED TO BE A SIGNIFICANT AMOUNT OF GREENISH BLACK SOFT TISSUE DEBRIS. THE TAPER WAS EXAMINED AND THERE WAS A SLIGHT AMOUNT OF GRAYISH MATERIAL CONSISTENT WITH A SMALL AMOUNT OF TAPER CORROSION, BUT OVERALL THE TAPER LOOKED FINE. THERE WAS SOME SCUFF MARKS ON THE POSTERIOR LATERAL ASPECT OF THE OF NECK OF THE PROSTHESIS POSSIBLY DUE TO IMPINGEMENT ON THE POSTERIOR ASPECT OF THE ACETABULAR COMPONENT. THE ACETABULUM APPEARED TO BE SIGNIFICANTLY ANTEVERTED. THERE WAS NO SIGNIFICANT BONY INGROWTH ON THE CUP. DOI: (B)(6) 2007; DOR: (B)(6) 2012; RIGHT HIP.

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

  MAUDE report 9739178 ↗
• InjuryJan 16, 2020Use of Device Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 2002, CD RECEIVED A LEFT THA. IN 2012, PATIENT BEGAN EXPERIENCING SYMPTOMS OF FATIGUE AND DIFFICULTIES WITH MEMORY AND MUSCLE WEAKNESS IN HER LEGS. IN 2017, PATIENT BLOOD COBALT LEVEL WAS 14.0 PPB AND HER URINE COBALT EVEL WAS 109.9. IN 2018, HER BLOOD COBALT LEVEL WAS 9.4 PPB AND HER URINE COBALT LEVEL WAS 35.6 PPB. SHE CONTINUED EXPERIENCING COGNITIVE ISSUE AND MENTAL FOGGINESS AND HAD PROGRESSION OF NEUROPATHIC WEAKNESS IN BOTH LEGS. AN FDG PET BRAIN SCAN SHOWED FOCAL AND GENERALIZED HYPOMETABOLISM CONSISTENT WITH CHRONIC TOXIC ENCEPHALOPATHY. IN 2019, HER LEFT THA WAS REVISED FOR SIGNIFICANTLY ELEVATED COBALT LEVEL, ADVERSE REACTION TO METAL DEBRIS, NON -UNION OF TROCHANTERIC OSTEOTOMY WITH PROXIMAL MIGRATION. THE REPLICA STEM WAS RETAINED AND THE COBALT CHROME METAL-ON- METAL HEAD ARTICULATION WAS REVISED TO A DEPUY ALTREX POLYETHYLENE NEUTRAL LINER AND A 36MM + 5 NECK LENGTH DELTA OPTION SLEEVED CERAMIC HEAD. THE BORE OF THE HEAD AND THE TRUNION OF THE RETAINED STEM SHOWED MODERATE CORROSION WEAR. THE COBALT CHROME FEMORAL HEAD SHOWED A WEAR ELIPSE. RETRIEVAL ANALYSIS OF THE EXPLANT SHOWED MINOR CORROSION WEAR OF THE ARTICULATING SURFACE OF THE COBALT

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Muscular Rigidity; No Code Available; Pain; Weakness

  MAUDE report 9596809 ↗
• InjuryOct 18, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES CUP LOOSENING AND PERIPROSTHETIC FEMUR FRACTURE. DOI: (B)(6) 2004; DOR: (B)(6) 2010; (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Pain

  MAUDE report 9210093 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, ELEVATED BLOOD METAL LEVELS AND DIFFICULTY AMBULATING. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION AND LOOSENING OF STEM. ADDED EXPIRY DATE OF THE HEAD AND AN IMPACTED PRODUCT RECORD FOR THE STEM, HOLE ELIMINATOR AND CUP WAS ADDED DUE TO ALLEGED INFECTION AND LOOSENING OF THE STEM. DOI: (B)(6) 2009; DOR: NONE REPORTED (LEFT HIP).

  Patient problems: No Code Available; Pain; Test Result; Unspecified Infection

  MAUDE report 9144975 ↗
• InjurySep 18, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES PATIENT SUFFERS FROM ELEVATED IONS. UPDATE 04/10/2017. PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES HIP, LEG, LOWER BACK PAIN, DAMAGE TO TISSUES, IMPAIRED WALKING, SITTING, STANDING ABILITY, IMPAIRED BALANCE, LOSS OF MOTION AND UNEVEN GAIT. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS INDICATED THAT THE PATIENT HAD PSEUDOTUMOR AND SMALL AMOUNT OF FLUID DISTENDING THE LEFT GREATER TROCHANTERIC BURSA. DATE OF REVISION WAS PROVIDED BUT NO REVISION OPERATIVE NOTES PROVIDED. NO LABORATORY FINDINGS PROVIDED FOR ALLEGED HIGH METAL IONS. UPDATE 09 OCT 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP AND FRACTURE (BONE AND COMPONENT). DOI: (B)(6) 2006. DOR: (B)(6) 2017, LEFT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 9081916 ↗