S-ROM ZTT 52-1485Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295170648), received between Jan 3, 2018 and Feb 10, 2022 — classified as 15 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016, DATE OF EVENT: (B)(6) 2022, (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Ambulation or Postural Difficulties; Fall; Joint Laxity; Pain

  MAUDE report 13505571 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. DOI: (B)(6) 2017; DOR; (B)(6) 2021: RIGHT HIP.

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

  MAUDE report 11507361 ↗
• InjuryDec 5, 2020Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2006 VIA THA. IT WAS REPORTED THAT GRADUALLY, OVER TIME, THE SLEEVE HAD BECOME MORE AND MORE MEDIAL, AND THE LATERAL FEMORAL CORTEX HAD BECOME WEAKER. THEN, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO THE LOOSENING OF THE IMPLANTS. THE SURGEON REPLACED ALL IMPLANTS WITH ANOTHER COMPANY'S IMPLANTS. (THE EXPLANTED CUP WAS JIDAI-TYPE CUP). THE REVISION SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT HAS DEAFNESS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10951470 ↗
• InjuryAug 13, 2020Unintended Movement; Migration; Unintended Movement; Migration

  THE PATIENT WAS REVISED TO ADDRESS STEM AND SLEEVE SUBSIDED APPROXIMATELY 1 CM. EXPLANTED ACETABULAR LINER, FEMORAL HEAD, SROM SLEEVE AND SROM STEM. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 10403451 ↗
• InjuryMay 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATES ASR REVISION, ORIGINALLY IMPLANTED BY THE SURGEON. COBALT LEVEL OF 4.4, CHROMIUM LEVEL OF 4.7. SROM STEM STAYED IMPLANTED. REVISED CUP TO A COMPETITIVE CUP, REPLACED SROM HEAD. NO FURTHER PATIENT INFORMATION AVAILABLE. DOI: (B)(6) 2008; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 10022287 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS LEFT FAILED METAL-ON-METAL LEFT TOTAL HIP ARTHROPLASTY WITH METALLOSIS AND ABDUCTOR MUSCLE NECROSIS. PATIENT HAD ELEVATED METAL ION LEVELS AND MRI CONSISTENT WITH METAL-ON-METAL CORROSION AND PSEUDOTUMOR FORMATION. PATIENT FELT DISCOMFORT. UPON ENTERING INTO THE JOINT, THE FLUID WAS UNDER TENSION AND HAD EVIDENCE OF METAL DEBRIS. THERE WAS EVIDENCE OF BOTH ABDUCTOR MUSCLE NECROSIS AND CAPSULAR TISSUE NECROSIS INVOLVING MORE THAN 25% OF ABDUCTOR MUSCLES. THIS WAS CAREFULLY AND EXTENSIVELY DEBRIDED. HE HAD A SMALL AMOUNT OF SHUCK TOLERATED HIP EXTENSION AND EXTERNAL ROTATION TO ABOUT 70 DEGREES, BUT THE HIP DISLOCATED WHEN THE HIP WAS FLEXED TO 90 DEGREES WITH ONLY 20 DEGREES OF HIP INTERNAL ROTATION. THE TAPER AND BEARING SURFACE OF THE FEMORAL HEAD HAD MINIMAL EVIDENCE OF CORROSION. THE TAPER ON THE STEM WAS IN GOOD CONDITION WITH NO EVIDENCE OF CORROSION. NECROTIC TISSUE WAS REMOVED FROM AROUND THE RIM OF THE ACETABULUM. THERE WAS EVIDENCE OF CORROSION AT THE TAPER OF THE LINER ACETABULAR COMPONENT INTERFACE WITH PSEUDOMEMBRANE FORMATION ON THE UNDERSURFACE OF THE ACETABULAR LINER. TH

  Patient problems: Discomfort; Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; No Code Available

  MAUDE report 9823499 ↗
• InjuryOct 15, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, NO REVISION DATE HAS BEEN PROVIDED. NO PART/LOT PROVIDED. LITIGATION ALLEGES THE PATIENT SUFFERS FROM DISCOMFORT AND ELEVATED TOXIC COBALT CHROMIUM METAL IONS. A STEM IS NOW BEING ADDED TO ADDRESS ALLEGATIONS OF ELEVATED TOXIC METAL IONS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2006; DOR: NONE REPORTED; (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Pain

  MAUDE report 9191298 ↗
• InjurySep 9, 2019Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2013. IT WAS REPORTED THAT IT WAS CONFIRMED THAT IMPLANTS WERE INSERTED IN A VARUS AT THE TIME OF THE PRIMARY SURGERY AND LOOSENED IN 6 YEARS.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8976618 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE AD 17 JUL 2018: RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO PREVIOUS ALLEGATIONS, PPF ALLEGES DISLOCATION AND INFECTION. UPDATED PART AND LOT NUMBERS OF UNKNOWN HEAD AND LINER. STEM, SLEEVE, CUP AND APEX HOLE ELIMINATOR WERE ADDED DUE TO ALLEGED INFECTION.

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

  MAUDE report 8477777 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS BEFORE FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8242177 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISIONS DUE TO PSEUDOTUMOR-LIKE IMAGES UNDER CT.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 8037465 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN AND DISCOMFORT IN HIP. IT BECAME INCREASINGLY PAIN TO WALK, MOVE THEIR LEGS, AND TO RISE FROM A SEATED POSITION. UPDATE: 11/15/12 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATED AD (B)(6): (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES LOOSENING OF CUP AND INFECTION. THERE IS NO REVISION NOTES PROVIDED. IT WAS INDICATED IN THE PPF THAT THE PLAINTIFF HAD A FIRST REVISION IN THE LEFT HIP ON NOV 19, 2015. UPDATED DATE OF REVISION. ADDED CUP, HOLE ELIMINATOR, SLEEVE AND STEM DUE TO ALLEGED INFECTION. DOI: (B)(6) 2005; DOR: (B)(6) 2015; (LEFT HIP).

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 7709971 ↗
• InjuryMay 8, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  COMPLAINT DESCRIPTION: NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT- LITIGATION ALLEGES PATIENT HAD PAIN AND SYMPTOMS OF A LOOSE IMPLANT AFTER ASR HIP IMPLANT. UPDATE: (B)(6) 2012- LITIGATION PAPERS WERE RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. PAPERS ALLEGE PATIENT SUFFERS FROM PAIN AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT UPDATE: (B)(6) 2012 - PLAINTIFF PRELIMINARY DISCLOSURE RECEIVED. THE SIDE OF BODY, DOI, AND PART/LOT INFO HAVE BEEN UPDATED. UPDATE REC'D 5/1/15 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 5/18/15 UPDATE ¿ 01/02/2017 SUPPLEMENTAL INFORMATION RECEIVED; LITIGATION ALLEGES THAT PATIENT UNDERWENT A REVISION TO ADDRESS PAIN AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT. STEM AND SLEEVE ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 10/26/2017 DOI: 0912/2006 - DOR: 12/17/2015 (RIGHT SIDE)

  Patient problems: Inadequate Osseointegration; Necrosis; No Code Available; Not Applicable; Osteolysis; Pain; Tissue Damage

  MAUDE report 7493918 ↗
• InjuryApr 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF AN UNKNOWN COMPONENT AT THE BONE TO IMPLANT INTERFACE. ALL COMPONENTS REMOVED AND REPLACED WITH PROSTALAC STEM, HEAD AND CUP. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: No Code Available; Not Applicable; Unspecified Infection

  MAUDE report 7410921 ↗
• InjuryJan 3, 2018Osseointegration Problem; Osseointegration Problem

  (B)(4). LITIGATION ALLEGES THAT PATIENT EXPERIENCED HIP PAIN, CAUSING DIFFICULTY AMBULATING AND SLEEPING. ADDITIONALLY, IT IS ALLEGED THAT IMPLANT IS RELEASING METAL IONS INTO PATIENT'S BODY. UPDATE DEC 05, 2017: PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES DEVICE FAILURE RESULTING TO INJURIES. AFTER THE REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS WEAR AND FEMORAL COMPONENT LOOSENING. CLINICAL NOTES REPORTED OF PAIN, DISCOMFORT, RESTRICTED ACTIVE AND PASSIVE RANGE OF MOTION, ANTALGIC GAIT AND RADIOGRAPHIC CRITERIA CONSISTENT WITH LOOSENING OF HIS HIP. LABORATORY RESULT FOR COBALT WAS BELOW 7PPB. ADDED STEM AND SLEEVE IMPACTED PRODUCTS. DOI: (B)(6) 2007; DOR: (B)(6) 2012; LEFT HIP.

  Patient problems: Discomfort; Host-Tissue Reaction; Inadequate Osseointegration; Injury; Loss of Range of Motion; Pain

  MAUDE report 7160021 ↗