S-ROM ZTT 55-0524Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295175292), received between Jan 9, 2017 and Apr 21, 2025 — classified as 52 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (11 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A THA SURGERY WITH S-ROM-A IMPLANTS FOR OA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, A REVISION SURGERY DUE TO SUSPECTED TRUNIONOSIS WAS SCHEDULED FOR (B)(6)2025. ACCORDING TO THE SURGEON, THE IMAGES SHOWED A TUMOR-LIKE SUBSTANCE AROUND THE HIP JOINT. INFECTION IS ALSO SUSPECTED, BUT THIS HAS NOT BEEN CONFIRMED. IN THE REVISION SURGERY, THE HEAD, STEM, AND LINER WILL BE REMOVED, AND THEN, THE TUMOR-LIKE TISSUE WILL BE REMOVED. AFTER THAT, A NEW LINER, STEM, AND HEAD WILL BE IMPLANTED. THE CUP AND LINER THAT HAD BEEN IMPLANTED IN THE THA (INITIAL SURGERY) WERE ZIMMER BIOMET¿S PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 21873211 ↗
• InjuryJun 28, 2024Degraded; Osseointegration Problem; Degraded; Osseointegration Problem

  PATIENT HAD A FAILED ACETABULAR COMPONENT ON METAL-ON-METAL TOTAL HIP WITH EVIDENCE OF TRUNNION CORROSION AND NO EVIDENCE OF INFECTION. DURING THE OPERATION, THERE WAS NO EVIDENCE OF PUS AND METALLOSIS BUT THERE WAS SOME MILD STAINING METALLIC-LOOKING IN THE INFERIOR ASPECT OF THE ACETABULUM. THERE WAS SOME MILD STAINING BEHIND THE LINER BUT VERY MINIMAL. THE STEM WAS GROSSLY LOOSE, HAD ROTATED INTO RETROVERSION AND WAS GROWN OVER WITH BONE. THE HEAD HAD SOME CORROSION OF THE TAPER. THE SLEEVE WAS THEN CUT USING SHARP DISSECTION BECAUSE IT WAS SCARRED DOWN. DOI: ON (B)(6) , 2009, DOR: ON (B)(6) 2014, LEFT HIP.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 19632333 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY NO DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: 03 JUN 2024. (RIGHT HIP). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 19567652 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE REACTION TO METAL DEBRIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2010. DATE OF EVENT: 04 APR 2024. (RIGHT HIP) TREATMENT: NONE.

  Patient problems: Foreign Body Reaction

  MAUDE report 19460851 ↗
• InjuryMar 18, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO STEM SUBSIDENCE AND REMOVED SROM STEM AND SLEEVE AND REVISED TO RECLAIM MOD STEM. IT WAS UNKNOWN THAT THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920635 ↗
• InjuryMar 22, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2005, THE PATIENT UNDERWENT THE PRIMARY SURGERY FOR LEFT HIP JOINT VIA THA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, ARMD AND IMPLANTS LOOSENING WERE CONFIRMED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE LINER IN QUESTION WAS REPLACED TO THE SAME SIZE AND THE TOTAL IMPLANTS ON THE FEMORAL SIDE WERE REMOVED AND REPLACED TO ARTIFICIAL JOINTS BY ZB. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT ARMD WAS THE CAUSE OF THE LOOSENING.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 16591534 ↗
• InjuryFeb 14, 2023Difficult to Remove; Difficult to Remove

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION: DATE OF IMPLANT: (B)(6) 2006. DATE OF REVISION: (B)(6) 2022. (RIGHT HIP) TREATMENT: REVISION; HEAD, LINER AND SHELL WERE REVISED.

  Patient problems: Cyst(s); Foreign Body Reaction; Low Blood Pressure/ Hypotension; Necrosis; Sepsis; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16371602 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SMALL CALCAR FX INTRAOPERATIVE; PERIPROSTHETIC FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022 DATE OF EVENT: (B)(6) 2022 (RIGHT HIP) TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 15979093 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  CORAIL PINNACLE WITH CERAMIC BEARINGS REVISED DUE TO UNKNOWN REASON OF OSTEOLYSIS. SOME MARKING WAS SEEN ON THE CUP AND HEAD, AND SOME BONE LOSS OBSERVED IN THE ACETABULUM AND FEMUR. REVISED TO AN S-ROM WITH G7 DUAL MOBILITY CUP, SURGEON WAS AWARE THAT THIS IS OFF LICENSE USAGE. NO PRODUCTS CODES ARE AVAILABLE FOR EXPLANTED IMPLANTS AS NO RECORDS. SURGEON DEEMED THAT THE CUP LOOKED STABLE, BUT THE STEM EXHIBITED SIGNS OF LOOSENING. RADIOGRAPHICALLY THESE LOOKED TO HAVE BEEN IMPLANTED IN THE CORRECT ORIENTATION. NO IMPLANTS ARE AVAILABLE AS THESE HAVE BEEN SENT TO ROYAL PERTH RETRIEVALS.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions; Osteolysis; Unspecified Tissue Injury

  MAUDE report 15925570 ↗
• InjurySep 23, 2022Fracture; Migration; Fracture; Migration

  UNF AND PINNACLE NON MOM MEDICAL RECORDS RECEIVED. INITIAL REPORTED REASON FOR REVISION ARE THE FOLLOWING FRACTURED PROSTHETIC FEMORAL STEM, PAIN, DISCOMFORT, CLICKING SENSATION, HETEROTOPIC BONE OSSIFICATION, IMPINGEMENT, METALLOSIS, AWAITING FOR MEDICAL RECORDS REVIEW TASK FINDINGS. ONCE AVAILABLE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. DOI: (B)(6) 2010; DOR: (B)(6) 2014 ; LEFT HIP.

  Patient problems: Discomfort; Extraskeletal ossification; Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 15474088 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORD RECEIVED. LITIGATION ALLEGES ELEVATED METAL IONS RESULTING TO HIP PAIN. DOI: (B)(6) 2007, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Necrosis; Pain; Swelling/ Edema

  MAUDE report 15138512 ↗
• InjuryMay 12, 2022Osseointegration Problem; Osseointegration Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM, PAIN AND STIFFNESS. DATE OF IMPLANT: (B)(6) 2016. DATE OF REVISION: (B)(6) 2019. (RIGHT HIP). REVISION OF THE HEAD, STEM AND LINER.

  Patient problems: Inadequate Osseointegration; Muscular Rigidity; Pain

  MAUDE report 14371960 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. PATIENT HAS UNDERGONE A FEW OTHER REVISIONS. DOI: SEVERAL YEARS AGO (STEM, CUP), DOI: (B)(6) 2021 (HEAD, LINER). DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13393407 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT THA COMPLETED DUE TO OSTEOARTHRITIS. A DEPUY ASR HEAD, ASR CUP, AND TAPER SLEEVE ADAPTER WERE USED. PATIENT COMPLETED OF AUDIBLE NOISE AND POPPING IN THE HIP. REVISION COMPLETED SECONDARY TO ADVERSE METAL-ON-METAL REACTIONS AND COBALT CHROMIUM TOXICITY. PATIENT HAD MODERATE ALVAL LIMITED TO THE CAPSULE WITH SMALL AMOUNTS OF TISSUE NECROSIS AROUND THE CAPSULE. DOI: (B)(6) 2007; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190910 ↗
• InjurySep 29, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM AND SLEEVE AT THE IMPLANT TO BONE INTERFACE. THE SURGEON REVISED THE STEM, SLEEVE AND HEAD TO THE RECLAIM SYSTEM. UPON TRIALING THE 75 BODY, THE SCREW THAT ATTACHES TO THE STEM BROKE INTO THREE PIECES. ALL OF THOSE PIECES WERE RETRIEVED. ROUGHLY 2 MINUTES OF ADDITIONAL TIME WAS REQUIRED TO SECURE THE BROKEN TRIAL BODY. DOI: (B)(6) 2020. DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12546885 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL ASR XL LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES PAIN, INJURY, ELEVATED COBALT AND CHROMIUM LEVEL, ACETABULAR CUP DETACHED/DISCONNECTED, METAL DEBRIS, LOOSENED ACETABULUM, WALKING DIFFICULTY, GRINDING AND CLICKING. DOI: (B)(6) 2007 : DOR: (B)(6) 2020 (LEFT HIP). MEDICAL RECORDS THEN RECEIVED AND REVIEWED: AFTER REVIEW OF THE MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP ARTHROPLASTY SECONDARY TO ADVERSE METAL ON METAL REACTION AND COBALT CHROMIUM TOXICITY. REVISION NOTES REPORTED OF MODERATE ALVAL LIMITED TO THE CAPSULE AND MODERATE CAPSULAR NECROSIS, IT WAS ALSO INDICATED THAT THERE IS A SMALL HIP EFFUSION AROUND THE FEMORAL NECK AND MILD SYNOVIAL THICKENING. LABORATORY RESULTS SHOWED ELEVATED COBALT SERUM LEVEL. STEM WAS NOT REVISED DURING REVISION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Necrosis; Pain; Swelling/ Edema

  MAUDE report 11895833 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF REVISION: (B)(6) 2019; (RIGHT HIP). TREATMENT: REVISION OF CUP, 2 SCREWS, HOLE ELIMINATOR, LINER, STEM, PROXIMAL SLEEVE, AND HEAD--PLACEMENT OF ANTIBIOTIC SPACER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10837620 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH AN INFECTED HIP. CULTURES REVEALED THAT THE PATIENT HAD TB AND STAPH. THE SURGEON DECIDED IT BEST TO REMOVE ALL IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10077711 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES PAIN, METAL TOXICITY, ANXIETY, STIFFNESS, DISCOMFORT, WEAKNESS WHICH AFFECTED THE PATIENT'S MOBILITY AND NORMAL PHYSICAL ACTIVITIES. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED LEFT HIP REPLACEMENT. OPERATIVE NOTES INDICATED HETEROTOPIC OSSIFICATION, SCAR, METALLOSIS WITH SOME DEBRIS NOTED IN THE SOFT TISSUES, OSTEOLYSIS, CORROSION IN MORSE TAPER, BONE LOSS, AREAS OF CYST POSTERIOR, SUPERIOR AND SLIGHTLY ANTERIOR WITH AREAS OF METALLIC DEBRIS WITHIN THE BONE. ADDED MEDICAL HISTORY, WEIGHT AND HEIGHT OF PATIENT. DOI: (B)(6) 2008 : DOR: (B)(6) 2018 (LEFT HIP).

  Patient problems: Adhesion(s); Anxiety; Cyst(s); Discomfort; Extraskeletal ossification; Foreign Body Reaction; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Osteolysis; Pain; Test Result; Weakness

  MAUDE report 10065766 ↗
• InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD RECEIVED. ASR DEPUY WAS IMPLANTED. PATIENT ALLEGES INJURY, PAIN, SUFFERING, EMOTIONAL DISTRESS,ECONOMIC LOSS, LOSS OF SERVICES, LOSS OF CONSORTIUM, TOXIC COBALT AND CHROMIUM METAL IONS AND PARTICLES WERE RELEASED INTO PLAINTIFF¿S BLOOD, TISSUE AND BONE SURROUNDING THE IMPLANT AND PSEUDOTUMORS. DOI: (B)(6) 2008. DOR: (B)(6) 2019; (LEFT HIP).

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

  MAUDE report 10061233 ↗
• InjuryApr 8, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PROXIMAL PORTION OF THE STEM FX.. DOI: UNKNOWN. DOR: (B)(6) 2020. RIGHT SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9940383 ↗
• InjuryMar 3, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT COMPLAINTS OF PERSISTENT PAIN. X-RAYS SHOW SOME OSTEOLYSIS IN THE PROXIMAL FEMUR, MRI SHOWS PSEUDOTUMOR AND SOME ELEVATED COBALT AND CHROMIUM LEVELS. THE PATIENT WAS THEN REVISED FOR METALLOSIS AROUND A METAL ON METAL LEFT HIP REPLACEMENT. OPERATIVE NOTES REPORTED THAT THERE WAS A LARGE AMOUNT OF SLIGHTLY CLOUDY YELLOW FLUID WITH SOME APPARENT DEBRIS IN IT. THERE WAS A FAIRLY LARGE PSEUDOTUMOR. THERE WAS A FAIR AMOUNT OF CORROSION ON THE TRUNNION. IT WAS NOTED THAT THE S-ROM COMPONENT WAS PLACED SIGNIFICANTLY IN ANTEVERSION AND THE SLEEVE WAS ALSO IN A LOT OF ANTEVERSION. THERE WAS SOME AREAS OF OSTEOLYSIS IN THE PROXIMAL FEMUR AND SOME OSTEOLYSIS IN THE ACETABULUM SUPERIOR AND POSTERIOR WALL. THERE WERE SOME SMALL CAVITY DEFECT BEHIND THE ACETABULUM. DOI: (B)(6) 2008; DOR: (B)(6) 2018; LEFT HIP.

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

  MAUDE report 9779547 ↗
• InjuryFeb 26, 2020Corroded; Naturally Worn; Corroded; Naturally Worn

  LITIGATION ALLEGES PATIENT HAD PAIN, POPPING, RATCHETING AND GRINDING IN AND AROUND HIP AND ELEVATED METAL ION LEVELS AFTER ASR HIP IMPLANT. ASR LITIGATION RECORD. MOTION TO RE-OPEN CASE AND AMENDED LITIGATION RECEIVED. LITIGATION ALLEGES PAIN, POPPING, RATCHETING AND GRINDING IN AND AROUND HER RIGHT HIP, ELEVATED METAL ION LEVELS AND EMOTIONAL DISTRESS. IT WAS REPORTED THAT, DURING REVISION THERE WAS A LARGE AMOUNT OF BROWNISH RED CLEAR FLUID WITHIN THE JOINT WITH A STRING SIGN OF APPROXIMATELY 1-1/2 INCHES, CONSISTENT WITH A PSEUDOTUMOR FLUID ACCUMULATION. DOI: (B)(6) 2007. DOR: (B)(6) 2017, (RIGHT HIP).

  Patient problems: Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; No Code Available; Pain; Synovitis; Test Result

  MAUDE report 9756996 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED RIGHT HIP ARTHROPLASTY, ADVERSE LOCAL TISSUE RESPONSE SECONDARY TO METAL DEBRIS AND TROCANTERIC FRACTURE. PRIOR TO REVISION, THE PATIENT ALLEGED PAIN AND INJURY. OPERATIVE NOTES INDICATED UPON ENTERING THE HIP, THERE WAS OBVIOUS DESTRUCTIVE LESION OCCURRING. UPON ENTERING THE JOINT SPACE UNDER PRESSURE WAS THIS METAL STAINED FIBER PURULENT EXUDATE, A VERY THICK GRANULAR TYPE OF TISSUE THAT WAS DESTRUCTIVE IN NATURE. THERE WERE PERIPHERAL OSTEOLYTIC LESIONS. THE ACETABULAR COMPONENT WAS WELL FIXED ALSO WITH THE STEM. THERE WAS SOME MILD DEGREE OF TRUNNION WHERE NOTED. LAB RESULT FOR CHROMIUM WAS ABOVE 7. DOI: (B)(6) 2009. DOR: (B)(6) 2018, RIGHT HIP.

  Patient problems: Bone Fracture(s); Foreign Body Reaction; Injury; No Code Available; Osteolysis; Pain

  MAUDE report 9681013 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN ASR WITH SROM STEM. THE HOSPITAL AND DOCTORS OFFICE HAD NO RECORD OF ORIGINAL SURGERY. SO IT IS UNKNOWN WHEN AND WHERE THEY WERE IMPLANTED. WE WERE UNABLE TO READ PRODUCT NUMBER ON THE SLEEVE AND ASR CUP. DOI: UNK. DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9569087 ↗