PINNACLE 1217-11-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295009085), received between Jan 4, 2018 and Mar 13, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Corroded” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2023Corroded; Corroded

  MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED IN THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS DEPRESSION, WALKING DIFFICULTY AND METALLOSIS. CLINICAL VISIT REPORTED PERSISTENT FOCUS OF OSSIFICATION OF THE RIGHT GREATER TROCHANTER. SURGICAL PATHOLOGY REPORTED TISSUE REACTION TO PARTICULATE IMPLANT MATERIAL AND IN THE SOFT TISSUE METALLIC PARTICULATE DEBRIS AND CORROSION PRODUCTS. ALHOUGH THERE IS ABUNDANT CORROSION PRODUCT AND METALLIC PIGMENT WITH SYNOVIAL TISSUE, THERE IS NOT A SIGNIFICANT ALVAL INDICATIVE OF AN IMMUNOGENIC REACTION. FEMORAL HEAD SHOWS CIRCULAR ABRASIVE WEAR. MICROSCOPIC DESCRIPTION DEMONSTRATE INTERFACE SYNOVIAL LIKE TISSUE SHOWING DENSE AND DIFFUSE SUB SYNOVIAL FIBROSIS AND ARE FOCI OF REACTIVE APPEARING SYNOVIAL HYPERPLASIA. MRI HIPS SHOWS PSEUDOTUMOR, ELEVATED METAL IONS, LATERAL PAIN AND BURSITIS.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Anxiety; Depression; Discomfort; Distress; Extraskeletal ossification; Fibrosis; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Muscular Rigidity; Osteolysis; Pain; Scar Tissue; Synovitis; Unspecified Tissue Injury

  MAUDE report 16529330 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED HIP. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16494601 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DAIR PROCEDURE FOR INFECTION. REVISION OF TOTAL HIP REPLACEMENT EXCHANGE OF FEMORAL HEAD AND PINNACLE METAL ACETABULAR LINER. PATHOLOGY SUGGESTIVE OF INFECTION HOWEVER QUESTIONS REGARDING THE INFLUENCE OF THE METAL ON METAL ARTICULATION ON REVISION WERE SUGGESTED. PRIMARY HIP IMPLANTED BY DR (B)(6) AT (B)(6) HOSPITAL. RIGHT SIDE HIP. DOI: (B)(6) 2006. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13366447 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF PRIMARY COMPONENTS. COMPONENTS WERE REMOVED DUE TO INFECTION.

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

  MAUDE report 11605647 ↗
• InjuryMar 27, 2020Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS DAMAGE TO HIS HIP JOINT AND BODY. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, ALLEGES PAIN, DISCOMFORT, DECREASED RANGE OF MOTION, DIZZINESS, BLURRED VISION, COLD SWEATS, HEADACHES, FATIGUE, LEG AND HIP WEAKNESS, AND ELEVATED COBALT AND CHROMIUM IONS. THE SURGEON'S REVISION OPERATIVE NOTE INDICATED "A FAIRLY LARGE INTRAMUSCULAR LIPOMA" LOCATED "DEEP TO THE GLUTEAL FASCIA". PATHOLOGY FOR THIS MASS WAS NEGATIVE. NOTED A "MODEST SIZED EFFUSION" IN THE POSTERIOR HIP CAPSULE. IDENTIFIED METALLOSIS-STAINED SYNOVIAL TISSUE WITHIN THE PSEUDOCAPSULE OF THE HIP. NOTED SOME "METALLOSIS STAINING ON THE TRUNNION" AND "WITHIN THE MORSE TAPER OF THE FEMORAL HEAD". ALSO INDICATED "CONSIDERABLE METALLOSIS STAINING ON THE POSTERIOR ASPECT OF PINNACLE LINER" AND "WITHIN THE ACETABULAR SHELL". NO METAL ION LAB VALUES AVAILABLE FOR REVIEW. STEM ADDED TO COMPLAINT. PATIENT ALLEGES METAL WEAR AND DAILY ACTIVITY LIMITATIONS. SURGICAL PATHOLOGY REPORTS MILD CHRONIC INFLAMMATION AND SKELETAL ATROPHY. THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, LOCAL ADVERSE TISSUE REACTION, LIMB INEQUALITY, PAIN, MECHANICAL RATCHETING OR MECHANICAL SYMPTOMS, ELEVATED COBALT A

  Patient problems: Adhesion(s); Blurred Vision; Discomfort; Dizziness; Edema; Fatigue; Foreign Body Reaction; Headache; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Weakness

  MAUDE report 9891597 ↗
• InjuryMar 28, 2019Difficult to Remove; Difficult to Remove

  REVISION THR - PSEUDOTUMOR CAUSING DISLOCATION (COBALT LEVELS 182) FROM MOM PINNACLE CUP/LINER/HEAD COMBINATION - ORIGINAL THR 2008. DEBRIDEMENT, HEAD AND LINER CHANGE PLAN - COULD NOT REMOVE METAL LINER - CUP EXPLANTED - NEW STRYKER CUP/LINER INSITU WITH OUR TS CERAMIC 36 +12 HEAD. PATIENT DID NOT EXPERIENCE A POST-OP DEVICE MALFUNCTION. PATIENT REQUIRED REVISION SURGERY AND HARDWARE REMOVAL DUE TO METALLOSIS AND A NEW LINER/HEAD REQUIRED AFTER REMOVAL OF MOM.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8459489 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT HIP REVISION; PRIMARY IMPLANT DATE: (B)(6) 2016. REASON FOR REVISION: PAIN, LEG LENGTH INEQUALITY. RELEVANT PATIENT PRE-EXISTING CONDITIONS/ COMORBIDITIES; RIGHT HIP REPLACEMENT INSITU. PATIENT ACTIVITY LEVELS; AMBULANT. UNKNOWN JRN: PINNACLE CUP 56MM. PINNACLE LINER 56 OD 32ID. CERAMIC HEAD 32+5. CORAIL STEM KA10.

  Patient problems: No Code Available; Pain

  MAUDE report 8436006 ↗
• InjuryMar 12, 2019Corroded; Corroded

  PINNACLE LITIGATION RECEIVED. LITIGATION ALLEGED FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PLAINTIFFS BLOOD. AS A RESULT HE BEGAN EXPERIENCING SEVERE PAIN, DISCOMFORT, INFLAMMATION, AND INJURY. DOI: (B)(6) 2010; DOR: (B)(6) 2013; RIGHT HIP.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Inflammation; Injury; No Code Available; Osteolysis; Pain; Tissue Damage

  MAUDE report 8413105 ↗
• InjuryJan 4, 2018Degraded; Difficult to Remove; Appropriate Device Problem Term/Code Not Available; Degraded; Difficult to Remove; Appropriate Device Problem Term/Code Not Available

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES THAT PATIENT SUFFERED CAPSULECTOMY, AND HEMATOMA. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS SYNOVITIS AND METALLOSIS. REVISION NOTES REPORTED OF INFLAMMATORY LOOK FLUID, GRAYING OF THE TISSUE, METALLOSIS WITHIN THE JOINT AND SOME CORROSION AT THE TAPER. IT WAS ALSO STATED IN THE REVISION THAT DUE TO CORROSION , THERE WAS SOME COLD WELDING OF THE LINER WITHIN THE CUP. CLINICAL VISITS REPORTED OF PAIN, LIMPS, GRINDING TYPE SENSATION, SEVERE DISCOMFORT AND TROCHANTERIC BURSITIS. IT WAS ALSO STATED THAT PATIENT HAD AN ELEVATED COBALT-CHROMIUM SERUM LEVELS, HOWEVER, THERE IS NO LABORATORY RESULTS PROVIDED. CUP WILL BE REPORTED SINCE IT WAS REMOVED. DOI: (B)(6) 2008; DOR: (B)(6) 2012; LEFT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Hematoma; Pain

  MAUDE report 7163385 ↗