S-ROM ZTT 55-0513Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295175230), received between Jun 21, 2017 and Oct 28, 2024 — classified as 22 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT; UPDATE RECEIVED FOR: DATE OF REVISION: (B)(6) 2024. TREATMENT/IMPACT: READMITTED ON (B)(6) 2024 FOR REVISION.

  Patient problems: Fall; Foreign Body Reaction; Pain

  MAUDE report 20545127 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE S-ROM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2022. THE S ROM WILL BE REPLACED WITH A CORAIL REVISION. THE REASON OF THE REVISION SURGERY IS UNKNOWN. THE IMPLANT WILL NOT BE RETURNED BECAUSE IT WILL BE DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15211123 ↗
• InjuryApr 7, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO METAL ON METAL WITH ULTIMA IMPLANTS. THERE WAS METALOSIS PRESENT AND CORROSION ON NECK TAPER. SURGEON WAS SUCCESSFUL REMOVING THE SROM STEM RATHER EASILY AND HAD TO WORK A BIT TO TAKE OUT SLEEVE. REPLACED SROM WITH ARCOS FROM ZIMMER. REPLACED METAL LINER WITH PINNACLE DUAL MOBILITY METAL LINER. THERE WAS LOOSENING AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2007. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 14041822 ↗
• InjurySep 29, 2021Degraded; Degraded

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORD, IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR FAILED LEFT THA WITH RECALLED METAL ON METAL ON METAL DESIGN WITH MASSIVE PELVIC ASSOCIATED BONE LOOSE AND PSEUDOTUMOR. OPERATIVE NOTES REPORTED THAT THERE WAS A CHRONIC NON-UNION OF GREATER TROCHANTERIC FRACTURE. THERE WAS A DENSE DARK GRAY ORGANIZED MASS PROTRUDING FROM THE POSTERIOR PSEUDO CAPSULE. THERE WERE AREAS WITHIN THE MASS OF FRANK NECROSIS. DEBRIDED INTRACAPSULAR TISSUE THAT WAS SIMILARLY CONSISTENT WITH PSEUDOTUMOR. THERE WAS GROSS EVIDENCE OF TAPER JUNCTION CORROSION WITH BLACK DEBRIS ALONG THE TRUNNION. THERE WAS EXTENSIVE BLACK NECROTIC PASTRY DEBRIS BEHIND THE CUP. THE ANTERIOR COLUMN WAS LARGELY ABSENT DOWN INTO A SIGNIFICANT PORTION OF THE PUBIC ROOT. THERE WAS ESSENTIALLY NO ANTERIOR WALL. THERE WAS A SIGNIFICANT CAVITY EXTENDING UP THE ILIUM SIMILARLY FILLED WITH BLACK PASTY DEBRIS THAT WAS DEBRIDED. DOI: (B)(6) 2009, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; Unspecified Tissue Injury

  MAUDE report 12547661 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO INFECTION. OPERATIVE NOTES REPORTED THAT AT THE DISTAL POINT OF THE PREVIOUS INCISION, THERE WAS A LARGE BUBBLE INDICATIVE OF AN EVOLVING SINUS TRACT THAT WAS DRAINING. IT WAS VERY ERYTHEMATOUS AND SWOLLEN. ONCE IT WAS INCISED A COPIOUS AMOUNT OF PUS COME POURING OUT. THERE WAS CLEARLY A DEHISCENCE THROUGH THE ILIOTIBIAL BAND FASCIA ALL THE WAY DOWN TO THE JOINT. THERE WAS STILL QUITE A BIT OF METAL STAINED TISSUE AS THIS WAS STARTED AS A METALLOSIS CASE. THE ABDUCTOR TENDON HAS A SIGNIFICANT METAL STAINING, HOWEVER IT WAS INTACT. WE COULD NOT DISIMPACT THE STEM FROM THE SLEEVE. A TROCHANTERIC OSTEOTOMY WAS PERFORMED. THERE WAS SOME MILD BONE LOSS THAT WAS SEEN ON THE CT IN THE POSTERIOR WALL AND SUPERIOR DOME, BUT NOTHING TOO SIGNIFICATION. IT WAS INDICATED THAT 3 PACK RBCS WERE GIVEN. ADDED REVISION DATE, HOSPITAL, SURGEON, NEW IPS, MEDICAL HISTORY, DOB, AGE, GENDER, RELEVANT LABS AND EVENT DATE. CORRECTED DOI OF STEM UPDATED CONCOMITANT PRODUCTS. DOI: (B)(6) 2003 (CUP,SCREWS,STEM,SLEEVE), DOI: (B)(6) 2019 (HEAD, LINER), DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Foreign Body Reaction; Hematoma; Impaired Healing; Loss of Range of Motion; Metal Related Pathology; Pain; Physical Asymmetry; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11664871 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION STATED THAT THE AFFECTED SIDE WAS THE RIGHT HIP.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10770385 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRIMARY OPERATIVE NOTES (B)(6) 2011 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. INTRA-OPERATIVELY, A SMALL CRACK IN THE FEMORAL TROCHANTER WAS SUSTAINED ON IMPACTION OF THE ZTT SLEEVE. THIS WAS TREATED WITH A CERCLAGE WIRE AND NOTED TO BE STABLE WITH NO EVIDENCE OF INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10507111 ↗
• InjuryJul 20, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT HAD PAINFUL HIP. LOOSENING OF THE SROM SLEEVE AT BONE TO IMPLANT INTERFACE WAS ALSO REPORTED. COULDN¿T READ LOT NUMBER OF HEAD BALL. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2014; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10295146 ↗
• InjuryJun 4, 2020Degraded; Loss of Osseointegration; Osseointegration Problem; Degraded; Loss of Osseointegration; Osseointegration Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008 VIA THA AT ANOTHER HOSPITAL (B)(6). IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE STEM (P/N: 900550210), THE SLEEVE (P/N: 550513), THE HEAD (P/N: 152190057), THE CUP (P/N: UNKNOWN) AND THE LINER (P/N: UNKNOWN) DUE TO SUSPICION OF ARMD, OSTEOLYSIS AND THE LOOSENING OF THE STEM AND THE CUP. DURING THE SURGERY, IT WAS CONFIRMED THAT THE IMPLANTS WERE SHOWED SIGN OF BLACK RING BUT THERE WAS NO BONE NECROSIS AND SOFT TISSUE NECROSIS. THE OSTEOLYSIS OCCURRED ON LARGE AREA. THE REVISION SURGERY WAS COMPLETED WITH NO SURGICAL DELAY. THE SURGEON REQUESTED TO INVESTIGATE THE STEM¿S JUNCTION PART (BETWEEN THE STEM TO NECK, SLEEVE AND INNER BOLL). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; No Code Available; Osteolysis; Pain

  MAUDE report 10119691 ↗
• InjuryMar 13, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT A STEM WAS LOOSE. DOI: (B)(6) 2015; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9829221 ↗
• InjuryOct 1, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS WITH PSEUDOTUMOR FORMATION WITH DESTRUCTION AND LOOSENING OF THE COMPONENTS. REVISION NOTES STATED THAT SOME BURSITIS WITH FLUID WAS FOUND. THE PROXIMAL METAPHYSIS WAS COMPLETELY CIRCUMFERENTIALLY LOOSE . THE LITIGATION ALLEGES THAT THE PATIENT EXPERIENCED BONE LOSS AND PHYSICAL LIMITATIONS, EXPERIENCED A FOOT DROP, EXTENSIVE METALLOSIS AND BONE DESTRUCTION, PSEUDOTUMOR FORMATION WITH BONE DESTRUCTION, AND METAL DEBRIS.

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Inflammation; Loss of Range of Motion; Metal Related Pathology; Nerve Damage; No Code Available; Osteolysis; Pain; Swelling/ Edema; Test Result; Unspecified Tissue Injury

  MAUDE report 9139508 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8976395 ↗
• InjuryAug 27, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, LOOSENING AND DIFFICULTY AMBULATING. UPDATE AD 8 AUG 2018. (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS AND LOOSENING OF THE STEM. UPDATED UNK HIP TO STEM AND ADDED SLEEVE TO THE COMPLAINT. DOI: (B)(6) 2003; DOR: NONE REPORTED; LEFT HIP. PATIENT HAS BILATERAL HIP IMPLANTS, PLEASE SEE (B)(4) FOR RIGHT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Inadequate Osseointegration; Inflammation; Pain

  MAUDE report 8935478 ↗
• InjuryApr 16, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF STEM AND BONE FRACTURE. DOI: (B)(6) 2003 - DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Pain

  MAUDE report 8518091 ↗
• InjuryMar 7, 2019Loss of Osseointegration; Loss of Osseointegration

  PFS ALLEGES POST TRAUMATIC STRESS DISORDER, DEPRESSION, SWELLING IN BOTH LEGS, LIMPING, INTENSE STRAIN TO THE MUSCLES, LIGAMENTS AND TENDONS AREA, AND USE OF CANE FOR MOBILITY. AFTER REVIEW OF MEDICAL RECORDS, IT WAS CONFIRMED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE LEFT FEMORAL COMPONENT RESULTING TO PAIN. OPERATIVE NOTE REPORTED FEMORAL SLEEVE WAS LOOSE WITH NO BONY INGROWTH. THERE'S NO SIGNS OF INFECTION AND DISLOCATION IN THE REVISION NOTE. BONE SCAN REPORTED INCREASED ACTIVITY AT THE FEMORAL SLEEVE SUGGESTIVE OF LOOSENING.

  Patient problems: Ambulation or Postural Difficulties; Depression; Discomfort; Distress; Inadequate Osseointegration; No Code Available; Pain; Swelling

  MAUDE report 8398625 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AND REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8048059 ↗
• InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TOTAL HIP REPLACEMENT: (B)(6) HOSPITAL. PRIMARY (B)(6) 2016. PATIENT UNDER WENT AT TOTAL HIP REPLACEMENT IN (B)(6) 2016, 6 MONTHS LATER HE HAS UNEXPLAINED PAIN IN THE JOINT, THE SURGEON FIRST THOUGHT IT WAS INFECTED AND TREATED THE PATIENT AS PER AN INFECTION. HE HAD FLUID COLLECTION, WITH HIGH METAL IONS REPORTED. THE SURGEON THEN THOUGHT IT COULD BE METALLOSIS. A STAGE ONE REVISION FOR INFECTION/METALLOSIS WAS PERFORMED. THE SURGEON WOULD LIKE THE PROSTHESIS INVESTIGATED TO HELP WITH THE REASONING AS TO WHAT COULD EVENT MAY HAVE CAUSED THIS ISSUE. HE WOULD ALSO LIKE THE PROSTHESIS SENT BACK TO HIM, AFTER DEPUY SYNTHES HAS CONCLUDED THEIR INVESTIGATIONS, TO SEND TO DR (B)(6) FOR FURTHER ANALYSIS.

  Patient problems: Not Applicable; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7918114 ↗
• InjuryApr 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS FEMUR FRACTURE AND STEM LOOSENING. LOOSENING OCCURRED AT THE BONE TO IMPLANT INTERFACE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7391645 ↗
• InjuryNov 30, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS INFECTION OF THE RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7072486 ↗
• InjuryNov 20, 2017Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS PAIN AND CUP MALPOSITIONED. IT WAS ALSO STATED THAT DOCTOR WENT IN AND PULLED SROM STEM AND THE SROM SLEEVE WAS LOOSE AT BONE TO IMPLANT INTERFACE. ALSO PULLED THE CUP AND LINER. WENT BACK IN WITH A SROM CALCAR REPLACING STEM AND NEW CUP.

  Patient problems: Pain

  MAUDE report 7044545 ↗
• InjuryOct 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DER IS STATES SROM STEM AND ASR CUP WAS REMOVED DUE TO PAINFUL HIP. ION LEVELS: CHROMIUM 10.2, COBALT 15.5.

  Patient problems: No Code Available; Pain

  MAUDE report 6957556 ↗
• InjuryJun 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL DER STATES THAT PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC OSTEOLYSIS OF THE FEMUR.

  Patient problems: Osteolysis

  MAUDE report 6658250 ↗