NA 1365-61-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295034032), received between Feb 26, 2015 and Sep 19, 2023 — classified as 25 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REMOVED A PINNACLE MODULAR MOM LINER AND 44+1.5 HEAD. THERE WAS PAIN AND ELEVATED SERUM ION LEVELS PRESENT BUT NO ACCESS TO CONFIRM THIS. DOI: (B)(6) 2010. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17774511 ↗
• InjuryApr 20, 2023Naturally Worn; Naturally Worn

  PINNACLE METAL ON METAL MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDIAL RECORDS THERE WAS NO INFORMATION PROVIDED PERTAINING TO PATIENT HARM AND DEVICE RELATED PROBLEM. NO REVISION RECORDS RECEIVED YET. DOI: OCT 30, 2007, DOR: FEB 22, 2023, RIGHT HIP.

  Patient problems: Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 16777437 ↗
• InjuryFeb 16, 2023Naturally Worn; Naturally Worn

  ON (B)(6) 2021 A MEDICAL EXAMINER CONFIRMED DURING THIS VISIT THAT ON (B)(6) 2021, THAT THE PATIENT HAD UNDERWENT EXCISIONAL RIGHT HIP ARTHROPLASTY, FOR RECENTLY PLACED RIGHT THA BECAUSE OF WOUND INFECTION, ANTIBIOTIC SPACER PLACED. DOI: (B)(6) 2009. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Adhesion(s); Distress; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 16385899 ↗
• InjuryDec 14, 2020Degraded; Degraded

  ADDITIONAL INFORMATION RECEIVED FROM MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT DEVELOPED SUBSEQUENT BILATERAL HIP PAIN SECONDARY TO METAL ION DISEASE. LEFT SIDE HAS PAIN, DYSFUNCTION AS WELL AS ELEVATED SERUM COBALT AND CHROMIUM LEVELS. THE PATIENT WAS THEN REVISED FOR METALLOSIS OF THE LEFT HIP FROM A METAL-ON-METAL THA. OPERATIVE NOTES REPORTED THAT THE UNDERLYING TRUNNION SHOWED SIGNS OF MILD CORROSION PARTICULARLY AROUND THE BASED OF THE TRUNNION WITH BLACKENING OF THE METAL. THERE WAS NO EVIDENCE OF GROSS PITTING OR DELAMINATION OF THE TRUNNION. THERE WAS SURROUNDING EVIDENT OF METALLOSIS IN THE INNER ASPECT OF THE HIP CAPSULE. THERE WAS A MILD AMOUNT OF TISSUE SCARRING IN THE INTERVAL BETWEEN THE LINER AND THE SHELL. DOI: (B)(6) 2007, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Insufficient Information; Pain

  MAUDE report 11003802 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE. NO SURGICAL DELAY. DOI: (B)(6) 2008. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 10984784 ↗
• InjuryOct 6, 2020Naturally Worn; Naturally Worn

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED PAIN, ELEVATED METAL ION LEVELS. OPERATIVE NOTES INDICATED EVIDENCE OF TRUNNIONOSIS WITH BLACK METAL DEBRIS AT THE TRUNNION. DURING OPERATION ANESTHESIA INFORMED THAT THE PATIENT WAS NOT DOING WELL IN FACT WENT INTO SEVERE BRADYCARDIA AND HYPOXIA AND AN EMERGENT CODE WAS CALLED AT WHICH POINT THEY SEALED THE WOUND WITH IOBAN EMERGENTLY FLIPPED THE PATIENT ONTO HIS BACK AND BEGAN CHEST COMPRESSION. THE PATIENT WAS SUCCESSFULLY RESUSCITATED AND WAS STABLE AFTER MULTIPLE MEDICATIONS GIVEN. DOI: (B)(6) 2008; DOR: (B)(6) 2019 RIGHT HIP.

  Patient problems: Atrial Tachycardia; Foreign Body Reaction; No Code Available; Pain; Test Result

  MAUDE report 10638184 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. UNF REPORTED THAT PATIENT HAD DEPUY PRODUCT REVISED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT HAD COMPLAINTS OF PAIN, DISCOMFORT, NUMBNESS AND ELEVATED METAL IONS. NO OPERATIVE RECORDS WERE PROVIDED FOR THE RIGHT HIP REVISION. DOI: (B)(6) 2009; DOR: (B)(6) 2018; RIGHT HIP. THE PATIENT HAS BILATERAL HIP IMPLANTS, PLEASE SEE PC-(B)(4) FOR THE LEFT HIP.

  Patient problems: Discomfort; Hypoesthesia; No Code Available; Pain; Test Result

  MAUDE report 9601894 ↗
• InjuryJan 17, 2020Naturally Worn; Naturally Worn

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT COMPLAINTS OF PAIN AND ROM. THE PATIENT WAS THEN REVISED FOR LOOSE ACETABULAR COMPONENT AND FAILED METAL ON METAL LEFT THA. OPERATIVE NOTES REPORTED THAT THE ACETABULAR COMPONENT WAS GROSSLY LOOSED. THERE WAS A SIGNIFICANT AMOUNT OF METALLIC PSEUDCAPSULE. THERE WAS SOME SUPERIOR WEAR FROM THE FEMORAL HEAD. IT WAS INDICATED THAT THE SCREW WAS BROKEN AND REMOVED WITH PLIERS. DOI: (B)(6) 2010; DOR: (B)(6) 2015; LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9601826 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE AFFECTED SIDE WAS RIGHT HIP.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 9564782 ↗
• InjuryJan 3, 2020Corroded; Degraded; Corroded; Degraded

  IT WAS REPORTED THAT THE PATIENT HAS ELEVATED METAL ION LEVELS PER THE DOCTOR THAT HAVE CONTINUED TO ELEVATE, AND ALSO HAD GROIN PAIN. THERE WAS CORROSION AT THE HEAD NECK JOINT. THERE WAS ALSO SOME FIBROUS TISSUE INSIDE THE CUP AFTER THE LINER WAS REMOVED. PATIENT WAS VERY DIFFICULT TO DISLOCATE. LINER WAS REMOVED AND HEAD WAS REMOVED. POLY LINER WAS IMPLANTED WITH A NEW TS CERAMIC HEAD. DOI: (B)(6) 2007; DOR: (B)(6) 2019, (RIGHT HIP).

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; Pain; Test Result; Unspecified Tissue Injury

  MAUDE report 9546698 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 9410303 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD METAL ON METAL LINER AND WAS REVISED DUE TO METALOSIS. DOI: 2007, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9162436 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD METAL ON METAL WITH PAIN AND HIGH ION LEVELS. SURGEON DID HEAD LINER EXCHANGE TO ELIMINATE THE METAL ON METAL. DOI: UNKNOWN, DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8744455 ↗
• InjuryApr 24, 2019Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

  CLAIM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF CLAIM AND MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND ASEPTIC LOOSENING OF CUP COMPONENT. STIFFNESS, LIMPING, CLICKING, POPPING, WEAKNESS AND NUMBNESS WERE ALSO NOTED. OPERATIVE NOTES REPORTED SLIGHTLY BROWN TENTED AND TRANSLUCENT FLUID, THE TISSUE IS STAINED DARK GRAY CONSISTENT OF METALLOSIS, TWO SUPERIOR CYSTS WERE CURETTED AND THERE WAS NO ACETABULAR BONY INGROWTH NOTED. WHEN REMOVING THE ACETABULAR SHELL, THREE SCREWS BROKE BUT ONLY ONE WAS FULLY EXTRACTED AND THE TWO SCREWS WERE RECESSED SINCE THEY WERE EMBEDDED INTO THE SCLEROTIC BONE. MRI REPORTED TROCHANTERIC BURSITIS. X-RAY REPORTED ASEPTIC LOOSENING OF ACETABULAR COMPONENT AND HAS METAL WEAR DEBRIS REACTION. DOI: (B)(6) 2010; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Cyst(s); Hypoesthesia; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage; Weakness

  MAUDE report 8544307 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT METAL ON METAL LINER AND HEAD WAS BEING REVISED FOR HIGH METAL ION LEVELS. DOI: (B)(6) 2009; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Test Result

  MAUDE report 8326213 ↗
• InjuryNov 21, 2018Adverse 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

  THE PATIENT'S METAL ON METAL HIP CONSTRUCT WAS REVISED DUE TO PAIN. SURGEON REMOVED THE METAL LINER AND REPLACED IT WITH A POLY LINER. DOI: (B)(6) 2009, DOR: OCT 29, 2018, LEFT HIP.

  Patient problems: Adhesion(s); Discomfort; Hypoesthesia; No Code Available; Pain

  MAUDE report 8094255 ↗
• InjuryOct 29, 2018Biocompatibility; Biocompatibility

  LITIGATION PAPERS ALLEGE AFTER PATIENT'S SURGERY, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. IT IS ALSO ALLEGED AS A RESULT, PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND GROIN. IT IS FURTHER ALLEGED PATIENT ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. IT IS ALSO ALLEGED PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANT. UPDATE AD 1 MAY 2018; THE RECEIPT OF PPF AND STICKER SHEETS. PPF HAS NO ALLEGATIONS AND NO REVISION REPORTED. THE UNKNOWN DEPUY PINNACLE HIP THAT WAS REPORTED IN WPC WAS UPDATED AND ADDED PRODUCT CODE AND LOT NUMBER. ADDED DOB OF THE PATIENT AND LAW FIRM IN THE FACILITY NAME.

  Patient problems: Discomfort; Inflammation; No Code Available; Pain; Test Result

  MAUDE report 8013779 ↗
• InjurySep 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS ELEVATED ION LEVELS IN BLOOD. HEAD AND LINER WAS REVISED. DOI: UNKNOWN. DOR: (B)(6) 2018. RIGHT HIP.

  Patient problems: Not Applicable; Test Result

  MAUDE report 7897462 ↗
• InjuryJun 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION ALLEGES PAIN AND DISCOMFORT. PINNACLE PPF RECORD AND IMPLANT STICKER RECEIVED. PPF HAS NO NEW ALLEGATIONS. DOI: (B)(6) 2007; DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: Discomfort; Not Applicable; Pain

  MAUDE report 7603368 ↗
• InjuryJun 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT- LITIGATION PAPERS ALLEGE THE PATIENT MAY HAVE TO UNDERGO PAINFUL AND RISKY REVISION SURGERY DUE TO THE HIP IMPLANT NOT FUNCTIONING AS INTENDED. UPDATE AD 04 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PINNACLE PPF RECORD. THERE WAS NO NEW ALLEGATION(S) REPORTED. IMPLANT STICKER WAS ALSO RECEIVED, WHICH PART AND LOT IDENTIFIED. ADDED PRODUCTS FROM STICKER SHEET SINCE THERE HAS BEEN NO REVISION AND IT IS A KNOWN POLY LINER WITH PAIN WAS ALLEGED PREVIOUSLY AND NO ALLEGATIONS OF METAL ON METAL ISSUES-WE CAN'T REALLY EXCLUDE ANY OF THE PRODUCTS AS THE CAUSE OF THE PAIN. LAWYER FIRM, MANUFACTURING DATES, EXPIRATION DATE, DOB WERE UPDATED AS WELL. DOI: (B)(6) 2009; DOR: NOT REPORTED; LEFT HIP.

  Patient problems: Pain

  MAUDE report 7562143 ↗
• InjuryApr 4, 2018Material Disintegration; Insufficient Device Problem Information; Material Disintegration; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED FOR UNKNOWN REASON. DOI: UNKNOWN. DOR: (B)(6) 2016 (LEFT HIP). UPDATE MAR 5, 2018: LITIGATION RECORDS RECEIVED. ADDED ASSOCIATED CONTACT. THERE IS NO ALLEGATIONS REPORTED.

  Patient problems: Host-Tissue Reaction; Not Applicable

  MAUDE report 7395613 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL DER RECEIVED THAT PATIENT WAS REVISED TO ADDRESS ADVERSE LOCAL TISSUE REACTION. (B)(6) 2007. (B)(6) 2017. RIGHT HIP.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 7167315 ↗
• InjuryOct 19, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS.

  Patient problems: Pain

  MAUDE report 6962904 ↗
• InjuryJun 15, 2017Corroded; Degraded; Naturally Worn; Noise, Audible; Corroded; Degraded; Naturally Worn; Noise, Audible

  PPF ALLEGES METAL WEAR.

  Patient problems: Discomfort; Fatigue; Foreign Body Reaction; Host-Tissue Reaction; Hypersensitivity/Allergic reaction; Inflammation; Metal Related Pathology; Necrosis; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 6642741 ↗
• InjuryFeb 26, 2015Naturally Worn; Insufficient Device Problem Information

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2009, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HIS LEFT SIDE. PATIENT HAS LARGE AMOUNTS OF COBALT-CHROMIUM METAL IONS AND PARTICLES IN HIS BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND GROIN. HE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANT. UPDATE 1/30/2015 - DISC 209 PFS AND MEDICAL RECORDS RECEIVED. PFS IDENTIFIED PATIENT DOB, HEIGHT AND WEIGHT. THE UNKNOWN HIP IS NOW BEING CHANGED TO AN UNKNOWN LINER, AND AN UNKNOWN HEAD AND STEM ARE BEING ADDED TO ADDRESS PREVIOUS ALLEGATIONS.

  Patient problems: Discomfort; Inflammation; No Code Available; Pain

  MAUDE report 4549241 ↗