NA 1365-34-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295033523), received between Oct 10, 2014 and Apr 17, 2026 — classified as 55 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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 55 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT WAS AN INFECTION CASE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24911138 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED HIP. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24489809 ↗
• InjuryMay 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON REMOVED HEAD AND LINER AND IMPLANTED CONSTRAINED LINER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22071859 ↗
• InjuryFeb 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21419870 ↗
• InjuryJan 15, 2025Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS EVENT WAS A HIP REVISION, NOT A KNEE REVISION. THERE IS NO REPORTED MALPOSITION OR UNDERSIZE OF COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 21158146 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS HAVING A REVISION SURGERY FOR SUSPECTED PSEUDOTUMOR RELATED TO METAL ON METAL IMPLANTS. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PSEUDO TUMOUR, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE :REVISION SURGERY REQUIRED , IS THE PATIENT PART OF A CLINICAL STUDY :UNKNOWN, IP-01860288. DEVICE PROPERTY OF :NONE, DEVICE IN POSSESSION OF :NONE, IP-01860289. DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-01860290. DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-01860291. DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-01860292. DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18004765 ↗
• InjuryAug 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO DISLOCATION. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2023. (RIGHT HIP). TREATMENT: HEAD AND LINER WERE REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 17651375 ↗
• InjuryAug 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO A DISLOCATED HIP. THE SURGEON FOUND IT BEST TO REMOVE THE CONSTRAINED LINER AND METAL FEMORAL HEAD AND REPLACE THEM WITH THE SAME PARTS. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17614062 ↗
• InjuryAug 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION REOCCURRENCE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2016. DATE OF REVISION #1: (B)(6) 2022. DATE OF REVISION #2: (B)(6) 2022. DATE OF EVENT: (B)(6) 2023 (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 17610457 ↗
• InjuryApr 1, 2022Naturally Worn; Naturally Worn

  (B)(6) MOM LITIGATION RECORD RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FOR HEAVY METAL RELEASED RESULTING TO INJURY TO MUSCLE, TISSUES, SCAR TISSUE FORMATION, METAL WEAR , LIMITED ADL. AND PAIN. PLAINTIFF ALSO SUFFERED EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2009; DOR: (B)(6) 2021; UNKNOWN HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 13976809 ↗
• InjuryJun 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  QUESTION: 1. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? 2. PLEASE PROVIDE LOT NUMBER OF HEAD. 3. PLEASE PROVIDE DATE OF IMPLANTATION. 4. PLEASE PROVIDE THE AFFECTED SIDE OF THE HIP. 5. PLEASE PROVIDE NAME OF REVISION SURGEON. ANSWERS FOR YOUR QUESTION: 1. NO DELAY IN SURGERY. 2. HEAD LOT NUMBER IS 9040052. 3. DATE OF IMPLANTATION IS (B)(6) 2021. 4. LEFT SIDE. 5 DR. (B)(6)

  Patient problems: Joint Dislocation

  MAUDE report 12010691 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PAINFUL TOTAL HIP, SURGEON ELECTED TO REVISE THE CUP TO A COMPETITOR AND EXCHANGE THE HEAD. DOI: (B)(6) 2009; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 12009036 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SROM STEM REVISED TO S&N DUAL MOBILITY DUE TO INSTABILITY. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 11343137 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT IS AN UNKNOWN DATE OR SITE OF THE ORIGINAL IMPLANTATION OF COMPONENTS. PRODUCT CODES & LOT #S LISTED BELOW ARE WHAT WAS REPORTED FROM THE SURGICAL FIELD. THE PATIENT WAS HAVING INCREASING PAIN AND INSTABILITY. THE SURGEON RECEIVED A COMPASSIONATE EXCEPTION TO USE A FEMORAL HEAD FROM MERETE SINCE DEPUY DOES NOT MAKE TS CERAMIC HEADS FOR SROM. SROM STEM AND SLEEVE REMAIN INSITU (NO PRODUCT CODES OR LOT #S AVAILABLE). SAME W PINNACLE CUP. HEAD AND LINER EXCHANGE PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10763255 ↗
• InjurySep 29, 2020Degraded; Degraded

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT REPRESENT WITH INCREASE PAIN AND DISCOMFORT. COBALT AND CHROMIUM LEVELS WERE ELEVATED, A METAL SUBTRACTION MRI SHOWED A LARGE FLUID COLLECTION, CONSISTED WITH ADVERSE TISSUE REACTION. THE PATIENT WAS THEN REVISED FOR FAILED RIGHT METAL ON METAL THA. OPERATIVE NOTES REPORTED THAT THERE WAS ABOUT 60 CC OF GRAYING FLUID EMANATED FROM WHAT APPEARED TO BE A PSEUDOTUMOR CONSISTENT WITH ADVERSE TISSUE REACTION. SOME NECROTIC APPEARING MATERIAL WAS DEBRIDED. THERE WAS SOME EVIDENCE OF MEMBRANE FORMATION AT THE METAL INTERFACES CONSISTENT MORE WITH METAL ON METAL REACTION VS POLYETHYLENE OSTEOLYSIS. THERE WAS A SIGNIFICANT AMOUNT OF BLACKISH CORROSION AT THE FEMALE PORTION OF THE FEMORAL HEAD. THERE WAS SOME CORROSION ON THE TAPER. DOI: (B)(6) 2009; DOR: (B)(6) 2019 RIGHT HIP.

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

  MAUDE report 10599811 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISM DIAGNOSED THE END OF (B)(6). EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT HIP).

  Patient problems: No Code Available; Pulmonary Embolism; Thrombosis

  MAUDE report 10072778 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE NOTES PROVIDE INFORMATION THAT THE PRIMARY LEFT THA INCLUDED AN ASR CUP AND HEAD, A ZTT FEMORAL SLEEVE, AND AN UNK DEPUY FEMORAL STEM. DATE OF IMPLANTATION AND PART/LOT INFORMATION WERE NOT PROVIDED. THESE PRODUCTS HAVE NOT BEEN PREVIOUSLY REPORTED. RECORDS INDICATE THE PRIMARY THA PROCEDURE OCCURRED 10 YEARS EARLIER BY A DR. EDWARDS IN LARAMIE, WYOMING. DOR: (B)(6) 2020: PATIENT RECEIVED A COMPLETE LEFT THR TO TREAT PAIN AND DISCOMFORT SECONDARY TO ARMD AND MASSIVE ACETABULAR AND FEMORAL OSTEOLYSIS. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED STAINED PERIARTICULAR SYNOVIAL TISSUE AND FLUID CONSISTENT WITH METALLOSIS AND FOREIGN BODY REACTION. THE PSEUDOCAPSULE WAS DEBRIDED. THERE WAS SOME DEFICIENCY OF THE GLUTEUS MEDIUS, WHICH WAS REPAIRED. THE ASR CUP WAS MALPOSITIONED AND HAD SIGNIFICANT ECCENTRIC WEAR WHICH PRODUCED THE METALLOSIS. UPON REMOVAL OF THE ASR CUP, THE SURGEON IDENTIFIED SIGNIFICANT RETROACETABULAR OSTEOLYSIS WHICH WAS REMOVED AND RECONSTRUCTED WITH FRESH FROZEN ALLOGRAFT. THE OSTEOLYTIC LESIONS IN THE ISCHIUM, PUBIS, AND SUPERIOR REGIONS OF THE ACETABULUM, WHICH REQUIRED THE REVISION CUP TO BE SECURED WITH SCREWS. THE ZTT FEMORAL

  Patient problems: No Code Available; Thrombosis

  MAUDE report 10072369 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS BROKEN INSERT. THERE IS LITTLE INFORMATION THAT WAS PROVIDED FOR THIS SURGERY FROM THE PATIENT. APPARENTLY HE HAS UNDERGONE MULTIPLE REVISION HIP SURGERIES BUT THE PATIENT COULDN¿T REMEMBER HOW MANY OR HIS LAST ONE. HE THINKS IT WAS 5 YEARS AGO IN BOSTON. HE HAD A LONG SROM STEM WITH A PINNACLE CONSTRAINED INSERT THAT WAS BROKEN. SURGEON REMOVED A BUNCH OF SYNOVIAL TISSUE AND TISSUE THAT LOOKED LIKE IT HAD METAL DEBRIS IN IT. SURGEON STATED AT ONE POINT HE HAD A METAL ON METAL IMPLANT. I DON¿T KNOW ANY OF THE SIZES OR IMPLANTS FROM PREVIOUS SURGERIES OR IF THIS PATIENT HAS EVER HAD A MDR REPORT DONE. WE REPLACED CONSTRAINED PINNACLE LINER AND SROM 36 METAL HEAD. DOI: 2014, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Test Result

  MAUDE report 9845594 ↗
• InjuryMar 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS MECHANICAL FAILURE, LEFT TOTAL HIP ARTHROPLASTY. PATIENT WAS NOTED TO HAVE ELEVATED METAL ION LEVELS AS WELL AS INCREASED PAIN AND AN MRI SCAN THAT SHOWED A PSEUDOTUMOR IN BOTH HIPS. REVISION NOTES STATED THAT THERE WAS BROWNISH FLUID UNDER PRESSURE THAT CAME OUT OF THE FASCIAL OPENING WHEN THE FASCIA LATA WAS SPLIT LONGITUDINALLY. THE POSTERIOR CAPSULAR SPACE WAS OPENED AND WAS DEBRIDED OF WHAT ESSENTIALLY WAS A PSEUDOTUMOR MEMBRANE WHICH WAS A BROWNISH MEMBRANE. THE NECK WAS NOTED TO HAVE SOME CORROSION. THE PROXIMAL STEM WAS CAREFULLY EVALUATED AND DID NOT APPEAR TO BE LOOSE. HEAD AND LINER WERE REMOVED. DOI: (B)(6) 2004. DOR: (B)(6) 2018. (LEFT HIP).

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

  MAUDE report 9833401 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS MECHANICAL FAILURE, RIGHT METAL-ON-METAL TOTAL HIP ARTHROPLASTY. PATIENT WAS NOTED TO HAVE ELEVATED COBALT CHROMIUM LEVELS TO A FAIRLY HIGH LEVEL. MRI SCAN SHOWED A PSEUDOTUMOR IN BOTH HIPS. REVISION NOTES REPORTED THAT AS THE CAPSULE WAS ENTERED, A LARGE AMOUNT OF FLUID WAS ENCOUNTERED. THERE WAS ALSO A COPIOUS AMOUNT OF CHEESY-LOOKING MATERIAL THAT CAME OUT OF THE JOINT. THE BROWNISH-GRAY SYNOVIAL MEMBRANE AROUND THE JOINT WAS LIKEWISE DEBRIDED USING A RONGEUR. THERE WAS A SIGNIFICANT EROSION AT THE HEAD-NECK TAPER. THE PROXIMAL FEMORAL AREA WAS CAREFULLY EVALUATED AND SOME OSTEOLYTIC MEMBRANE WAS REMOVED FROM THE TROCHANTERIC AREA. HEAD AND LINER WERE REMOVED. THERE WAS A BONY PROMINENCE ANTERIORLY ON ACETABULAR SIDE AND WAS REMOVED USING A CURVED OSTEOTOME AND A RONGEUR. THE STEM WAS IN 0 DEGREES ANTEVERSION OR PERHAPS EVEN 1 TO 2 DEGREES OF RETROVERSION. AN ATTEMPT WAS MADE TO TRY TO BACK THE S-ROM STEM OUT USING A CHISEL BETWEEN THE PROXIMAL SLEEVE AND THE NECK. HOWEVER, IT WAS NOT POSSIBLE TO GET THE STEM TO DISLODGE, AND THE DECISION WAS MADE THAT RATHER THAN RISK SIGNIFICANT DAMAGE TO THE UPPER FEMUR BY TRYING

  Patient problems: Edema; Hypersensitivity/Allergic reaction; No Code Available; Osteolysis; Pain; Pocket Erosion; Test Result

  MAUDE report 9825880 ↗
• InjuryMar 10, 2020Naturally Worn; Naturally Worn

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A FAILED LEFT TOTAL HIP ARTHROPLASTY WITH PAIN AND SIGNS OF METALLOSIS. OPERATIVE FINDINGS INCLUDE SEVERE REACTIVE METALLOSIS, SOFT TISSUE DAMAGE, EROSION, SIGNIFICANT AMOUNT OF WEAR ON THE SURFACE OF THE HEAD AND BLACK METALLIC APPEARING RUST OVER THE TRUNNION. SAMPLES TAKEN FROM A CYST AND PSEUDOTUMOR WERE SENT TO THE LABORATORY FOR ANALYSIS. DOI: (B)(6) 2004; DOR: (B)(6) 2016; (RIGHT HIP).

  Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain; Pocket Erosion; Tissue Damage

  MAUDE report 9813619 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVED FOREIGN BODY REACTION PATIENT HARM.

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

  MAUDE report 9780066 ↗
• InjuryMar 2, 2020Noise, Audible; Noise, Audible

  PFS, PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES ELEVATED METAL IONS AFTER THE FIRST REVISION. PFS ALLEGES PAIN, SUFFERING AND VERTIGO. AFTER REVIEW OF MEDICAL RECORDS, VISIT NOTES ON (B)(6) 2017 INDICATED THAT THE PATIENT COMPLAINS OF A CLUNK ON THE RIGHT HIP WITH SPASM. DOI: (B)(6) 2017; DOR: NONE REPORTED. (RIGHT HIP). PLEASE SEE (B)(4) FOR THE 1ST REVISION.

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

  MAUDE report 9775127 ↗
• InjuryNov 20, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS UNSTABLE AND SO THE SURGEON WENT BACK IN FOR A REVISION SURGERY OF HER PRIMARY SROM HIP. UPON ENTERING THE JOINT CAPSULE, IT WAS DISCOVERED THERE WAS METALOSIS. THE METAL LINER, SROM HEAD, AND STEM WERE REMOVED AND ALL THREE WERE REPLACED. THE METAL WEAR SEEMED TO HAVE COME FROM THE HEAD/NECK JUNCTION AND NOT THE HEAD/LINER INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9348807 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A METAL ON METAL /S-ROM HIP IN 2003. HAS RECENTLY DEVELOPED RIGHT HIP PAIN AND MRI SHOWS FORMATION OF PSEUDOTUMOR ELEVATED METAL ION LEVELS. PATIENT WAS BROUGHT TO THE OR FOR REMOVAL OF METAL HEAD AND LINER ON (B)(6) 2019. NEW METAL HEAD AND POLYETHYLENE LINER WERE PUT PLACE. PATIENT ALSO HAD OSTEOLYSIS. DOI: (B)(6) 2003. DOR: (B)(6) 2019. RIGHT HIP.

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

  MAUDE report 9295516 ↗