SUMMIT 1570-12-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295060185), received between Sep 1, 2017 and Jan 12, 2026 — classified as 48 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SUMMIT DUOFIX TAP SZ7 HI OFF, DEPUY ASR XL FEM IMP SIZE 53, ASR ACETABULAR IMPLANT 60, AND TAPER SLEEVE ADAPTER 12/14 +8 WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED INFECTION OF ASR HIP IMPLANTS, WITH THE PATIENT REQUIRING HOSPITALIZATION AND TREATMENT UNDER INFECTION PROTOCOLS. ALL IMPLANTS WERE KEPT IN SITU AS NO REPLACEMENT PRODUCTS WERE AVAILABLE, AND NO REVISION SURGERY WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 24039119 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE (B)(6) 2024 MEDICAL RECORDS RECEIVED. PATIENT UNDERWENT REVISION DUE TO REMOVAL OF PREVIOUS COBALT CHROME HIP BALL IN COBALT CHROME METAL LINER. RIGHT HIP SYNOVECTOMY WAS ALSO DONE. AS THE JOINT SPACE WAS ENTERED, TAN COLORED FLUID WAS IDENTIFIED. THIS WAS ASPIRATED WITH A SYRINGE AND SENT FOR SYNOVIAL FLUID ANALYSIS AS WELL AS CULTURE. THE APPEARANCE OF THE FLUID WAS CONSISTENT WITH METALLOSIS AND TRUNNIONOSIS. REACTIVE SYNOVITIS WAS LIKEWISE IDENTIFIED AS THE JOINT SPACE WAS ENTERED. REPLACEMENT DEVICES WERE NON MOM IMPLANTS. DOI: (B)(6) 2007. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP. THIS IS A BILATERAL HIP ARTHROPLASTY. THIS IS A LINK TO (B)(4).

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Synovitis

  MAUDE report 18787217 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE AD 15 FEB 2024 MEDICAL RECORDS RECEIVED. PATIENT UNDERWENT REVISION DUE TO ELEVATED COBALT LEVELS- REMOVAL OF COBALT CHROME HIP BALL AND COBALT CHROME ACETABULAR LINER. SLIGHTLY CLOUDY YELLOW SYNOVIAL FLUID IN MODERATE QUANTITY, ASSOCIATED WITH REACTIVE, TAN-COLORED SYNOVITIS CONSISTENT WITH METALLOSIS, TRUNNION CORROSION IDENTIFIED. THIS INCLUDED SMALL THIN PIECES OF DARK STAINED MATERIAL ADHERENT TO THE BASE OF THE TRUNNION. PERIPROSTHETIC OSTEOLYSIS AND WEAR OF ARTICULAR BEARING SURFACE. FOR PLACEMENT WITH HIGHLY CROSS-LINKED POLYETHYLENE LINER AND REVISION OF CERAMIC HIP BALL. DOI: (B)(6) 2009, DOR: (B)(6) 2021. AFFECTED SIDE : LEFT HIP. THIS IS A BILATERAL HIP ARTHROPLASTY. A LINK OF (B)(4).

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 18769352 ↗
• InjuryApr 20, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  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: (B)(6) 2007. DOR: (B)(6) 2023. RIGHT HIP.

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

  MAUDE report 16777438 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER A REVIEW OF MEDICAL RECORDS, IT WAS NOTED THAT THERE WAS SIGNIFICANT OSTEOLYSIS OF THE PROXIMAL FEMUR. HIP CAPSULECTOMY WAS DONE AND DURING THIS PROCESS, A LARGE SIGNIFICANT AMOUNT OF WHITE HEMATURIA WAS EXPRESSED FROM THE JOINT. THERE WAS EXTREMELY HIGH PRESSURE. SIGNIFICANT TRUNNIONOSIS OF THE FEMORAL TRUNNION WITH THE FEMORAL HEAD, SIGNIFICANT METALLOSIS WITH TRUNNIONOSIS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Distress; Foreign Body Reaction; Hematuria; Inflammation; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 16528957 ↗
• 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 13366451 ↗
• InjurySep 28, 2021Degraded; Degraded

  ASR CLAIM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED METAL ON METAL TOTAL HIP ARTHROPLASTY DUE TO ELEVATED CHROMIUM AND COBALT LEVELS, TRUNNIONS ASSOCIATED WITH ADVERSE LOCAL TISSUE REACTION. UPON ENTERING THE HIP JOINT, BLACK FLUID APPEARED ALMOST LIKE ENGINE OIL WAS PRESENT. FEMORAL HEAD WAS REMOVED AND SMALL AMOUNT OF BLACK MATERIAL WAS NOTED AT THE HEAD NECK JUNCTION. THE CUP WAS SLIGHTLY VERTICAL BUT ACCEPTABLE AND SLIGHTLY DECREASED ANTEVERSION BUT ALSO IN ACCEPTABLE RANGE. DOI: (B)(6) 2009. DOR: (B)(6) 2020, LEFT HIP.

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

  MAUDE report 12539839 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS "PRODUCTS WERE REMOVED DUE TO A PERIPROSTHETIC FRACTURE. IMPLANTS WERE NOT THE CAUSE OF THE FRACTURE." DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Limb Fracture

  MAUDE report 11790887 ↗
• InjuryFeb 15, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WIT A LOOSE FEMORAL STEM. THE HEAD AND STEM WERE EXPLANTED AND A HIGH OFFSET CORAIL WAS REIMPLANTED. LOOSENING AT THE BONE TO IMPLANT INTERFACE. PAIN DUE TO THE LOOSENING STEM. NO DELAY DURING SURGERY. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11328088 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR FAILED RIGHT THA WITH ELEVATED METAL ION AND POSITIVE MARS MRI CONSISTENT WITH A PSEUDOTUMOR WITH SOFT TISSUE POCKETS OF FLUID, AND PERSISTENT PAIN. OPERATIVE NOTES REPORTED THAT THERE WAS A COPIOUS AMOUNT OF LIQUID IN THE HIP JOINT. FROZEN SECTION WAS NEGATIVE FOR INFECTION. SOME OF THE ABDUCTORS WERE DEBRIDED. THERE WAS SOFT TISSUE NECROSIS DIFFUSELY AROUND THE HIP. NO LABS REPORTED FOR THE ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2009. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 10601242 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN, DISCOMFORT, EMOTIONAL DISTRESS, DISABILITY AND DISFIGUREMENT. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES, LIMITED ABILITY TO WALK, ELEVATED METAL IONS, MENTAL ANGUISH AND ANXIETY. AFTER REVIEW OF MEDICAL RECORDS, IT WAS MENTIONED ON RADIOLOGY REPORT THAT THE PATIENT HAD A FALL, NO FRACTURE WAS NOTED ON X-RAY, HOWEVER, MRI ON (B)(6) 2018 REPORTED GREATER TROCHANTERIC FRACTURE. THE STEM HAS BEEN ADDED TO THE COMPLAINT. ADDED RELEVANT LAB, PATIENT HEIGHT AND WEIGHT. DOI: (B)(6) 2009; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Deformity/ Disfigurement; Discomfort; Edema; Fall; Fibrosis; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain

  MAUDE report 9900455 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR UNKNOWN REASON. NO SIGNS OF METALLOSIS. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Injury; No Code Available; Pain; Test Result

  MAUDE report 9646959 ↗
• InjuryOct 18, 2019Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS PASSED AWAY. DATE OF DEATH: (B)(6) 2019.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Foreign Body Reaction; No Code Available; Pain; Test Result

  MAUDE report 9207827 ↗
• InjuryOct 16, 2019Naturally Worn; Naturally Worn

  REASON FOR REVISION: REACTION TO METAL ON METAL ARTICULATION. MAIN SOURCE OF METAL DENIES APPEARS TO BE NECK TRUNNION. MAJOR SIGNIFICANT TISSUE STAINING, ATROPHY OF SOFT TISSUE INCLUDING ABDUCTOR SOFT TISSUE. SIGNIFICANT PSEUDO TUMOR AND SIGNIFICANT AMOUNTS OF GRANULAR TISSUE. SIGNIFICANT PELVIC BONE LOSS. FEMORAL COMPONENT INSITU HOWEVER ACETABULAR AND ENTIRE ARTICULATING SURFACE REVISED AND REPLACED. 157012135; SUMMIT SIZE 7H DUOFIX FEMORAL COMPONENT; LOT NO:A38E11000- STILL IMPLANTED.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; No Code Available

  MAUDE report 9199190 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGED LUMP ON HIS HIP. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESSED INFECTION. UPON INCISION WAS MADE THERE WAS A SIGNIFICANT AMOUNT OF PURULENCE, PUS AND NECROTIC MATERIAL UNDER PRESSURE THAT DID SHOOT OUT ONCE THE INCISION WAS OPEN. AT THE DOWN LEVEL OF FASCIA LATA AND GLUTEUS FASCIA THERE WERE FAIRLY LARGE AT LEAST THUMB SIZED HOLES IN THE FASCIA THAT WHEN PALPATED WENT ALL THE WAY DOWN TO THE JOINT. THERE WAS EXTENSIVE AMOUNT OF SCAR MEMBRANE AND GRANULOMATOUS FORMATION ON BOTH OF THESE COMMUNICATION. ADDED HEIGHT AND WEIGHT OF PATIENT. DOI: (B)(6) 2005; DOR: (B)(6) 2011; LEFT HIP.

  Patient problems: Adhesion(s); Discomfort; Host-Tissue Reaction; Necrosis; No Code Available; Pain; Test Result; Unspecified Infection

  MAUDE report 9191270 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION. DOI: (B)(6) 2016, (HEAD,LINER), (B)(6) 2009 (CUP,SCREW,STEM). DOR: (B)(6) 2016, (LEFT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9120506 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED TO ADDRESS DISCOMFORT. UPDATE REC'D 08/01/2016- WAIVER OF SUMMONS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. UPDATE AD 21 AUG 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND IMPLANT RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2009. DOR: (B)(6) 2016, (LEFT HIP).

  Patient problems: Discomfort; No Code Available; Test Result

  MAUDE report 9120376 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON MAY 19, 2017: LEGAL MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, WEAKNESS, SWELLING IN BOTH LEGS, GRINDING AND CLICKING UPON BENDING. PATIENT WAS ADVISED FOR REVISION WHEN PAIN IS PERSISTED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, THERE ARE NO LABORATORY RESULTS OR EXAMINATION NOTES FOR THE ALLEGED SWELLING AND CLICKING. SHALL THERE BE ANY INFORMATION RECEIVED, THIS COMPLAINT WILL BE UPDATED. UPDATE AD 8 AUG 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2007; DOR: NONE REPORTED, (RIGHT HIP). PATIENT IS BILATERAL. SEE (B)(4) FOR LEFT HIP.

  Patient problems: Pain; Swelling; Test Result; Weakness

  MAUDE report 8939528 ↗
• InjuryAug 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED ALLEGING PAIN AND METAL ON METAL. AFTER REVIEW OF THE REVISION NOTE THERE WAS NO MENTION OF A METAL ON METAL REACTION. IT DID NOTE THE CUP WAS PROTRUDED, SO THE CUP IS BEING REPORTED. AT THE END OF THE REVISION OPERATION THERE WAS A LEG LENGTH DISCREPANCY, BUT THE SURGEON EXPECTED THIS BASED ON THE NEW CUP THAT WAS INSERTED SO THE STEM ISN'T BEING REPORTED AT THIS TIME. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. ADDED PATIENT'S AGE, PRODUCT'S EXPIRATION DATE, PATIENT HARMS AND AN IMPACTED PRODUCT RECORD FOR THE STEM WAS ADDED DUE TO ALLEGED ELEVATED METAL IONS. UPDATED PATIENT INITIALS. IPS WERE NOT CODED WITH METALLOSIS AS IT WAS PREVIOUSLY REPORTED THAT THERE WAS NO MENTION OF METAL ON METAL REACTION ON THE REVISION NOTES. DOI: (B)(6) 2006. DOR: (B)(6) 2013, (LEFT HIP). PATIENT IS A BILATERAL.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8905815 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES WAS REVISED TO ADDRESS SEVERE METALLOSIS CAUSING CARDIAC INJURY AND HIP PROSTHESIS FAILURE. PPF ALLEGES PSEUDOTUMOR, METAL WEAR, ELEVATED METAL IONS AND BONE FRACTURE. STEM HAS BEEN ADDED DUE TO THE ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2007; DOR: (B)(6) 2016; LEFT HIP.

  Patient problems: Injury; No Code Available; Test Result; Tissue Damage

  MAUDE report 8711626 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A TWIST WITH A POP AND PAIN FOLLOWED BY A FALL. SHOWING A RIGHT FEMUR PERI PROSTHETIC FRACTURE. RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8555131 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2013, (RIGHT HIP).

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8526924 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 XPLANTED - 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; Test Result; Tissue Damage

  MAUDE report 8459487 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2005; DOR: (B)(6) 2015 (RIGHT HIP).

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8436816 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: (B)(6) 2016 (RIGHT HIP). PATIENT IS BILATERAL.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8424489 ↗