PINNACLE POROCOAT 1217-01-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10603295008576), received between Jul 20, 2017 and Oct 22, 2025 — classified as 1 death, 67 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (13 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 73 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO INFECTION. STAGE 1 REVISION. DOI: (B)(6) 2025. DOR: (B)(6), 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23357967 ↗
• InjuryJun 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REVISED FOR DISLOCATION. DURING SURGERY IT WAS DETERMINED THE CUP WAS NOT IN A GOOD POSITION, AND THE STEM WAS SEATED TOO LOW. ALL COMPONENTS WERE REMOVED. A NEW CUP, LINER, STEM, AND HEAD WAS IMPLANTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED AREA: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22329548 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LEFT TOTAL HIP REVISION DUE TO FAILED METAL ON METAL LEFT HIP TOTAL REPLACEMENT. OSTEOPHYTES FOUND. DOI: (B)(6) 2010. DOR: (B)(6) 2015. AFFECTED AREA: LEFT HIP.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19620260 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF THE MEDICAL RECORDS, SURGICAL PATHOLOGY REPORTED CUP, HEAD AND STEM WERE REVISED. CONVEX SURFACE OF THE CUP REPORTED SLIGHTLY GRANULAR AND CONTAINS A SCANT AMOUNT OF RED, POROUS, GROSSLY UNREMARKABLE BONE. REASON FOR REVISION WAS NOT SPECIFY. DOI: (B)(6) 2009. DOR: (B)(6) 2024. RIGHT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 19559067 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO OSTEOLYSIS. DATE OF IMPLANT: (B)(6) 2004 DATE OF REVISION: (B)(6) 2024 (LEFT HIP) TREATMENT: HEAD, LINER, AND CUP WERE REVISED

  Patient problems: Osteolysis

  MAUDE report 19231615 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR CARDIOVASCULAR COMPLICATIONS (E.G. MI). EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2005. DATE OF EVENT: 14 MAR 2024. (LEFT HIP). TREATMENT: NONE.

  Patient problems: Myocardial Infarction

  MAUDE report 19019514 ↗
• InjuryMay 2, 2023Osseointegration Problem; Osseointegration Problem

  ON (B)(6) 2021: PATIENT HAS A CONSULT REGARDING HIS RIGHT HIP WITH PERSISTENT SWELLING THAT HAS OCCURRED NEARLY A YEAR AFTER HIS REVISION. HE HAS BEEN ASPIRATED SEVERAL TIMES WITH NO SIGNS OF INFECTION. CHROMIUM AND COBALT LEVELS ARE NORMAL. HE HAS SOME NUMBNESS AND PAIN RADIATING DOWN THE BACK OF HIS LEG. MRI SHOWS A VERY LARGE PSEUDOTUMOR AROUND THE RIGHT HIP THAT HAS RECURRED AS WELL AS POSSIBLE LOOSENING OF THE RIGHT CUP. X-RAY REVIEW SHOWS OSTEOLYSIS AROUND THE STEM PROXIMALLY ON THE MEDIAL SIDE. ON (B)(6) 2022: PHYSICAL THERAPY NOTE INDICATES PATIENT HAD A SECOND PSEUDOTUMOR REMOVAL FROM HIS HIP ON (B)(6) 2021. HE HAS WEAKNESS AND DIFFICULTY WALKING REQUIRING PHYSICAL THERAPY TREATMENTS. IT IS UNKNOWN IF ANY IMPLANTS WERE REVISED. ON (B)(6) 2022: PATIENT CANCELS PHYSICAL THERAPY VISITS DUE TO EXCESSIVE ¿POPPING SOUNDS¿ IN HIS HIP. DOI: (B)(6) 2020; DOR: UNKNOWN; RIGHT HIP SECOND COMPLAINT.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Fatigue; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Metal Related Pathology; Numbness; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16852332 ↗
• InjuryMar 13, 2023Corroded; Corroded

  MEDICAL RECORDS INDICATE THAT THE PATIENT WAS REVISED TO ADDRESS ABDUCTOR REPAIR OF THE RIGHT HIP. THE OPERATIVE NOTE REPORTED TO HAVE EXTENSIVE DESTRUCTION OF THE PERIARTICULAR SOFT TISSUES. THE ABDUCTOR INSERTION WAS AVULSED AND ERODED IN THE ANTERIOR THIRD OF THE GREATER TROCHANTER. THERE WERE COPIOUS AMOUNTS OF CHOCOLATE BROWN FLUID EVACUATED, SCAR TISSUE, CAPSULAR SLEEVE, AND REPAIR HAD BEEN ERODED BY PSEUDOTUMOR. A SCIATIC NEUROPLASTY WAS PERFORMED. THOROUGH DEBRIDEMENT IS DONE OF THE PSEUDOTUMOR, NODULAR SYNOVITIS. THE FEMORAL HEAD SHOWED SEVERE CORROSIVE DEBRIS. MILD BONE LOSS IN THE POROUS COATING NO NEED FOR STEM REVISION. THERE IS A SIGNIFICANT DEBRIDEMENT OF THE SCAR AND HETEROTOPIC OSSIFICATION WAS DONE IN THE FEMUR. THE CLINICAL VISIT REPORTED FLUID BUILD ON HIS LATERAL HIP AND FOR EXAMINED. THE PATIENT HAD PAIN AND WEAKNESS AND SOME OTHER VAGUE CONSTITUTIONAL SYMPTOMS WHICH MAY OR MAY NOT BE RELATED TO HIS HIP. POSITIVE FOR ARTHRALGIAS AND JOINT SWELLING, TENDERNESS IN THE GREATER TROCHANTER AND LATERAL. LEG LENGTH IS 5-8 MM SHORT. ASSOCIATED MILD SOFT TISSUE EDEMA. MRI IMPRESSION WITH LARGE APPEARING PERIPROSTHETIC FLUID COLLECTION WITH LARGE PSEUDOTUMOR. ELEVATED M

  Patient problems: Adhesion(s); Discomfort; Distress; Extraskeletal ossification; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Muscle/Tendon Damage; Necrosis; Pain; Physical Asymmetry; Pocket Erosion; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 16530407 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 15605052 ↗
• MalfunctionAug 8, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT INTRAOPERATIVELY, AFTER IMPACTING THE CUP AND SCREWING IN THE HOLE ELIMINATOR, THE SURGEON WANTED TO CORRECT THE POSITION OF THE CUP. IN ORDER TO INSERT THE CUP IMPACTOR, THE APEX HOLE ELIMINATOR SHOULD HAVE BEEN REMOVED, WHICH UNFORTUNATELY WAS NOT POSSIBLE. THE SURGEON DECIDED TO INSERT THE INLAY AND REPOSITION THE HIP. AS A RESULT OF THE TRIAL REPOSITION THE HIP DISLOCATED AND THE CUP WAS COMPLETELY CHANGED. NO PATIENT HARM REPORTED. THERE WAS A 30 MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 15182821 ↗
• InjuryJul 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION WAS DUE TO THE PINNACLE LINER BEING DISASSOCIATED FROM THE SHELL. THE CERAMIC HEAD WAS ARTICULATING DIRECTLY INTO THE PINNACLE SHELL. THE ARDS OF THE LINER HAD EITHER BEEN WORN AWAY OR HAD BROKEN OFF. DOI: UNK. DOR: UNK. UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 15111706 ↗
• InjuryJun 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR. WM HAD A PATIENT SHOW UP IN HIS CLINIC WITH A DISASSOCIATED PINNACLE LINER. THIS PATIENT HAD TO UNDERGO A REVISION SURGERY WHERE BOTH THE ORIGINAL CUP AND LINER WERE REVISED (REVISION WAS DONE ON (B)(6) 2022). THIS PATIENT IS AN ACTIVE MALE, AND HAD HIS ORIGINAL SURGERY 6 MONTHS PRIOR (I DO NOT HAVE THE ACTUAL DATE). THE DISSOCIATION OCCURRED 6 MONTHS POST-OP, WHERE PRIOR TO THIS INCIDENT HE WAS DOING EXCELLENT AND BACK TO DAILY LIVING. THE ORIGINAL SURGERY WAS DONE USING A 100 SERIES CUP AND A 36X56 NEUTRAL LINER. THE SURGEON DOES A VERY THOROUGH JOB AT EXAMINING HIS LINERS INTRA-OP, AND WAS NOT PLEASED WITH THIS COMPLICATION. THIS IS ALL THE INFORMATION I HAVE. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? YES, IF YES, PLEASE DESCRIBE. PLEASE SEE EVENT DESCRIPTION. PATIENT NEEDED TO BE ADMITTED FOR REVISION SURGERY , DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPT

  Patient problems: Insufficient Information

  MAUDE report 14803842 ↗
• InjuryApr 29, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT, THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 14249902 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORD RECEIVED. PATIENT ALLEGES PAIN, ELEVATED METAL ION, FATIGUE, TUMOR THAT CAUSED BY METALLOSIS DUE TO THE INITIAL IMPLANT OF THE METAL-ON-METAL PINNACLE DEVICE, HEMARTHROSIS, NUMBNESS AND DISCOMFORT, FLUID ACCUMULATION, BLEEDING INTO THE HIP JOINT, AND SWELLING. PATIENT DEVELOPED A FOOTBALL-SIZED PSEUDOTUMOR AND RELATED NECROSIS, CAUSED BY METALLOSIS DUE TO THE INITIAL IMPLANT OF THE METAL-ON-METAL PINNACLE DEVICE CAUSING HIM EMOTIONAL DISTRESS. PLAINTIFF SUSTAINED AND CONTINUES TO SUFFER DAMAGES, INCLUDING, BUT NOT LIMITED TO SUFFERING, SEVERE AND POSSIBLY PERMANENT INJURIES, DISABILITY, DISFIGUREMENT, ECONOMIC DAMAGES (INCLUDING MEDICAL AND HOSPITAL EXPENSES) MONITORING, REHABILITATIVE AND PHARMACEUTICAL COSTS, AND LOST WAGES AND LOSS OF FUTURE EARNINGS CAPACITY, INABILITY TO WALK WITHOUT A CANE, BONE LOSS, PARASTHESIA IN RIGHT LEG, MARK DISTENTION IN RIGHT HIP, DEBRIS, KIDNEY CANCER, THYROID ISSUES, BELL'S PALSY, AND VERTIGO. DOI: (B)(6) 2005; OR: (B)(6) 2020 ; (RIGHT HIP).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Deformity/ Disfigurement; Discomfort; Distress; Extraskeletal ossification; Fatigue; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Necrosis; Numbness; Osteolysis; Pain; Paresthesia; Physical Asymmetry; Pocket Erosion; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury; Vertigo; Wound Dehiscence

  MAUDE report 13306495 ↗
• InjuryJun 3, 2021Use of Device Problem; Use of Device Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED LEFT FAILED TOTAL HIP ARTHROPLASTY WITH SQUEAKING METAL ON METAL ARTICULATION. ONCE WE ENTERED THE JOINT THERE WAS RELEASE OF DARKLY FLUID. THICK GRAY REACTIVE SYNOVITIS WITH MULTIPLE AREAS OF BLACK DENSE MATERIAL SCATTERED THROUGH THE SYNOVIUM. METALLOSIS WAS TRACKED ALONG THE ACETABULAR AND NECK OF FEMORAL COMPONENT BONE INTERFACE. IT WAS OBVIOUS THAT THE ACETABULAR COMPONENT WAS TOO VERTICAL. DOI: (B)(6) 2005 DOR: ((B)(6) 2011 LEFT HIP. PLEASE SEE (B)(4) FOR RIGHT HIP.

  Patient problems: Foreign Body Reaction; Synovitis

  MAUDE report 11932203 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, LITIGATION REPORTED THAT THE PLAINTIFFS REVISION INVOLVED, IN PART, A FINDING OF AN ADVERSE TISSUE REACTION RELATED TO THE METAL-ON-METAL ARTICULATION, RELEASE OF A LARGE AMOUNT OF BROWNISH FLUID, AND DEBRIDEMENT AND REMOVAL OF BROWNISH FRIABLE TISSUE THROUGHOUT THE ENTIRE HIP JOINT, ALL DUE TO TOXIC HEAVY METAL/METAL ION COBALT AND CHROMIUM POISONING.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia; Depression; Discomfort; Distress; Dyspnea; Extraskeletal ossification; Fall; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Muscle/Tendon Damage; Numbness; Pain; Paresthesia; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 11826440 ↗
• InjuryMar 24, 2021Corroded; Corroded

  PATIENT RECEIVED PRIMARY HIP-TEP RIGHT SIDE WITH MOM ON (B)(6) 2007. HE IS REPORTING PAIN AND INCREASED COCR-LEVELS. REVISION OF ACETABULAR COMPONENTS ON (B)(6) 2021. PATIENT PRESENTED TO THE ATTENDING PHYSICIAN ON (B)(6) 2020, FOR UNSPECIFIED SYMPTOMS, FOR WHICH CT SCAN AND X-RAYS "SHOWED EXTENSIVE OSTEOLYSIS, MOST LIKELY IN LINE WITH ABRASION DUE TO THE METAL/METAL TRIBOLOGICAL PAIRING IN THE AREA OF THE TROCHANTER REGION". SUBSEQUENTLY, THE (UNSPECIFIED) SYMPTOMS INTENSIFIED. ADDITIONAL X-RAYS SHOWED THAT THE OSTEOLYSIS HAD BROKEN THROUGH THE TROCHANTER REGION AND THAT A MINOR PLATE HAD FRACTURED OFF, ALTHOUGH THE TROCHANTER REGION REMAINED INTACT. NO LABS WERE PROVIDED THAT ADDRESSED METAL ION LEVELS. A RIGHT TOTAL HIP REVISION TOOK PLACE ON (B)(6) 2021, TO ADDRESS "PRONOUNCED METALLOSIS (SYSTEMIC AND LOCALIZED) WITH OSTEOLYSIS IN THE LATERAL GREATER TROCHANTER REGION ON THE RIGHT WITH METAL ON METAL IMPLANT FAILURE (IMPLANTATION 2007)". THE METAL LINER WAS REPORTEDLY "IMMOVABLY CORRODED" TO THE DEGREE THAT THE CUP AND LINER (WITH HOLE ELIMINATOR) HAD TO BE EXPLANTED AS A WHOLE CONSTRUCT. CUP, HOLE ELIMINATOR, METAL LINER, AND FEMORAL HEAD WERE ALL REVISED TO COMPETITOR PRODUCT

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

  MAUDE report 11566053 ↗
• MalfunctionFeb 25, 2021Difficult to Insert; Difficult to Insert

  HCP REPORTED TO BFARM: "HOLE ELIMINATOR SLIPPED THROUGH CUP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378846 ↗
• InjuryFeb 4, 2021Use of Device Problem; Use of Device Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS DISLOCATION AND METALLOSIS ON (B)(6) 2007, THE PATIENT HAD A RIGHT PRESS-FIT TOTAL HIP ARTHROPLASTY TO ADDRESS END-STAGE OSTEOARTHRITIS. DEPUY COMPONENTS WERE UTILIZED, INCLUDING S-ROM STEM. THE CUP WAS NOTED TO HAVE BEEN PLACED IN ABOUT 40-45 DEGREES OPEN ABDUCTION AND ABOUT 25 DEGREES ANTEVERSION THAT MATCHED HER VERSION ANATOMICALLY. THERE WERE NO COMPLICATIONS NOTED DURING THE SURGERY. ON (B)(6) 2021, THE PATIENT HAD A REVISION RIGHT TOTAL HIP ARTHROPLASTY WITH ACETABULAR CUP/LINER AND FEMORAL HEAD, TO ADDRESS FAILED RIGHT HIP, RECURRENT INSTABILITY, METALLOSIS WITH MILD ADVERSE REACTION TO METAL DEBRIS. THE PATIENT HAS HAD MULTIPLE DISLOCATION WHICH INCLUDED PAIN AND SWELLING PRIOR TO SURGERY. THE SURGEON INCLUDED IN HIS FINDINGS: MILD ADVERSE REACTION TO METAL DEBRIS, MOST LIKELY IMPINGEMENT OF THE NECK ON THE METAL LINER, MILD TRUNNIONOSIS ¿LITTLE BIT OF LYSIS AND/OR JUST STRESS SHIELDING IN THE BONE IN THE ACETABULUM, AND A PSEUDOTUMOR. THE ACETABULAR CUP WAS NOTED TO BE ¿SLIGHTLY MALPOSITIONED, SLIGHTLY VERTICAL, SLIGHTLY OVER-ANTEVERTED¿. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROC

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 11278998 ↗
• MalfunctionDec 11, 2020Difficult to Insert; Difficult to Insert

  INTRAOPERATIVELY THE HOLE ELIMINATOR SLIPPED THROUGH THE CUP´S HOLE. IT SLIPPED THROUGH THE SOCKET AND BEHIND THE CUP AND DID NOT STOP LIKE IT SHOULD. IT WAS LEFT IN THE SPACE BEHIND THE CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991540 ↗
• MalfunctionNov 18, 2020Difficult to Insert; Difficult to Insert

  DESCRIPTION OF COMPLAINT: WHEN THE SURGEON TRIED TO INSERT THE APEX HOLE ELIMINATOR, THE IMPLANT DIDN'T STOP AS IT WAS SUPPOSED TO. THIS IS THE SECOND TIME THE SURGEON HAS EXPERIENCED THIS. SURGEON STOPPED TIGHTENING THE APEX HOLE ELIMINATOR BEFORE IT WENT THROUGH THE CUP.

  Patient problems: No Code Available

  MAUDE report 10860375 ↗
• MalfunctionNov 16, 2020Difficult to Insert; Difficult to Insert

  APEX HOLE ELIMINATOR DOESN'T FUNCTION CORRECTLY. PATIENT : NO HARM NOR ANY DELAY. NO MORE INFO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10843714 ↗
• DeathNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEATH, SECONDARY TO POSSIBLE GASTROINTESTINAL BLEED. EVENT SERIOUS AND IS CONSIDERED SEVERE/FATAL. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS REMOTE POSSIBILITY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF REVISION (NON-STUDY HIP): (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020 (DAY UNKNOWN) (RIGHT HIP). TREATMENT: NONE.

  Patient problems: Death; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10838550 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SOFT TISSUE INFECTION WITH POSSIBLE DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF EVENT (ONSET): (B)(6) 2020; (RIGHT HIP). TREATMENT: NONE (AWAITING SURGICAL I&D WITH POSSIBLE REVISION).

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10559981 ↗
• InjuryJul 9, 2020Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ACCORDING TO THE SURGEON, PATIENT EXPERIENCED PINNACLE LINER DISSOCIATION, AS EVIDENCED ON X-RAY. THIS FINDING WAS CONFIRMED INTRA-OP. MULTIPLE ARD TABS WERE BROKEN OFF OF THE LINER. THE SURGEON ELECTED TO KEEP THE PINNACLE SHELL, REPLACING THE LINER AND FEMORAL HEAD. DOI: (B)(6) 2003; DOR: (B)(6) 2020; RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 10252004 ↗