S-ROM ZTT 55-0501Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295175179), received between Apr 10, 2018 and Sep 14, 2026 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Osseointegration Problem

  It was reported that patient had pain in hip. Lucency around sleeve. There was loosening of Sleeve and stem at unknown interface with unknown cement manufacturer. Stem looked tight distal. Stem, Sleeve, Head, and Poly were removed. Reclaim Monobloc Short Stem was implanted and poly was changed to a 10 degree.Affected Side: Right Hip

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 50754129 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE MORE 15 YEARS AGO, THE PATIENT UNDERWENT AN INITIAL THA SURGERY WITH THE PRODUCT IN QUESTION. AFTER THE SURGERY ON (B)(6) 2025, IT WAS CONFIRMED FROM THE X-RAY OF THE CASE OF POST-THA SURGERY INFECTION THAT THE STEM WAS SROM-A AND THE CUP WAS A PRODUCT OF ANOTHER COMPANY. THE PATIENT UNDERWENT SURGERY MORE THAN 15 YEARS AGO, BUT THE EXACT DATE IS UNKNOWN. THE SECOND SURGERY IS SCHEDULED ON (B)(6) 2025 TO REMOVE THE IMPLANT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 23412781 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN INITIAL SURGERY WITH THE PRODUCTS IN QUESTION. AFTER THE SURGERY ON (B)(6) 2025, THE BREAKAGE OF THE STEM CALCAR WAS CONFIRMED. THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Limb Fracture

  MAUDE report 23074226 ↗
• InjuryMay 15, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD A REVISION OF LEFT HIP. THE STEM WAS LOOSE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19323954 ↗
• InjuryFeb 27, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA BHA FOR WITH THE IMPLANTS IN QUESTION AT ANOTHER HOSPITAL. ON AN UNKNOWN DATE, IT WAS CONFIRMED THAT THE STEM WAS LOOSE. THEREFORE, THE IMPLANTS IN QUESTION ARE SCHEDULED TO BE REMOVED ON (B)(6) 2024, AND REPLACED BY ANOTHER COMPANY'S PRODUCT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18789716 ↗
• InjuryAug 30, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT ON UNKNOWN DATE IN EARLY DECEMBER 2021, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE OTHER COMPANY¿S OVATION STEM FOR THE LEFT HIP JOINT. AFTER THE SURGERY, THE FRACTURE OF THE FEMORAL STEM OCCURRED. ON (B)(6) 2021, THE INITIAL REVISION SURGERY WAS PERFORMED WITH THE SROM STEM, THE SLEEVE, AND THE HEAD. AFTER THE INITIAL REVISION SURGERY, THE STEM LOOSENED AND SANK, SO THAT THE SECOND REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2022. THE STEM AND POSSIBLY THE SLEEVE ARE ALSO SUNKEN, AND THE STEM WILL BE REPLACED WITH STRYKER¿S STEM. THE PATIENT STATUS IS UNKNOWN. ACCORDING TO THE SURGEON, THIS IS DIFFICULT CASE WITH BMI IN THE LATE 30S. THE POSSIBLE CAUSES OTHER THAT THE PRODUCTS ARE HIGH BMI. THE SALES REP HAS NOT HEARD ANY COMMENTS REGARDING THE PRODUCTS FROM THE SURGEON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15320701 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT BEGUN EXPERIENCING RIGHT THIGH PAIN OVER TIME. HER PAIN WAS LOCALIZED OVER THE DALL-MILES CABLES AND HETEROTOPIC OSSIFICATION AT THE PROXIMAL 1/3 FEMORAL DIAPHYSIS. THE PATIENT PERFORMED A SURGERY ON ((B)(6) 2019) FOR RIGHT FEMUR REMOVAL OF HARDWARE AND EXCISION OF HETEROTOPIC OSSIFICATION. NO OTHER HIP IMPLANTS WERE REVISED. XRAY REPORTED MILD SURROUNDING SOFT TISSUE EDEMA. DOI: (B)(6) 2005; (STEM,SLEEVE,CUP,SCREW); DOI: (B)(6) 2018; (HEAD,LINER); DOR: NONE REPORTED; RIGHT HIP. PLEASE SEE (B)(4) FOR 1ST REVISION OF RIGHT HIP.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9883052 ↗
• InjuryFeb 4, 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 INFECTED LEFT TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES INDICATED PUS AROUND THE PROSTHESIS. HE HAS BEEN BACK ON 3 OCCASIONS FOR DRAINAGE AND IT WAS PURULENT. DOI: (B)(6) 2009; DOR: (B)(6) 2009; (LEFT HIP).

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9664831 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 07 JAN 2020 WERE REVIEWED ON 09 JAN 2020 BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PRIMARY OPERATIVE NOTES (B)(6) 2012 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REPLACEMENT WITH 1-STAGE FEMORAL SHORTENING DUE TO CROWE IV CONGENITALLY DISLOCATED HIP. A FEMORAL BONE FRAGMENT WAS GENERATED AND THEN SECURED BY CERCLAGE WIRE FOR BONE GRAFTING. DOI: (B)(6) 2012. DOR: NO REVISION REPORTED (RIGHT HIP).

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

  MAUDE report 9631724 ↗
• InjuryJan 13, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CRUSH FRACTURE OCCURRED DURING THE REVISION SURGERY ON (B)(6) 2019 (THE REVISION SURGERY WAS REPORTED ONCE AS (B)(4). THE SURGEON WAS PLANNING TO REMAIN THE STEM (P/N: 900526210) WITH THE SLEEVE (P/N: 550501) AND PERFORMED HEAD TRIAL HOWEVER DISLOCATION OCCURRED DUE TO LEG LENGTH MISMATCH. THEREFORE, THE SURGEON ATTEMPTED TO REMAIN THE SLEEVE AND EXPLANT ONLY THE STEM WITH A DEDICATED STEM EXTRACTOR FOR REPLACING THE STEM, BUT IT COULD NOT BE DONE. ORIGINALLY, DESPITE BEING IMPLANTS THAT CAN BE EASILY REPLACED, THE STEM AND THE SLEEVE WERE COMING OUT TOGETHER WHEN S/HE ATTEMPTED TO EXPLANT ONLY THE STEM AGAIN. AT THE SAME TIME, A PART OF THE PROXIMAL MEDIAL PART OF THE FEMUR AND THE GREATER TROCHANTER WERE CRUSHED FRACTURE AND BLEEDING HEAVILY. THUS, A SROM STEM WHICH WAS PREPARED FOR THE PATIENT COULD NOT USE. SINCE THE SURGERY COULD NOT CONTINUE DUE TO CRUSH FRACTURE OCCURRENCE, THE WOUND WAS CLOSED, AND THE 2ND REVISION SURGERY WAS SCHEDULED TO BE PERFORMED IN (B)(6) 2020 (DATE OF SURGERY WAS NOT FIXED YET). THE SURGERY WAS CLOSED BY 100 MINUTES SURGICAL DELAY. THE PATIENT HAD TO STAY IN BED DUE TO LACK OF STEM IN FEMUR, AND SO THERE WAS CONCERNS ABOUT MUSCL

  Patient problems: Bone Fracture(s); No Code Available; Not Applicable

  MAUDE report 9581281 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS AFTER THE FIRST REVISION. DOI: (B)(6) 2016; DOR: NONE REPORTED (LEFT HIP, SECOND EVENT).

  Patient problems: Burning Sensation; Edema; Pain

  MAUDE report 9495379 ↗
• InjuryOct 1, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2007 ON THE PATIENT¿S RIGHT HIP JOINT VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE HEAD (P/N: 1521900579), THE LINER (P/N: 124148000), THE STEM (P/N: 900526210) WITH THE SLEEVE (P/N: 550501) DUE TO LOOSENESS, BREAKAGE OF THE STEM, THIGH PAIN CAUSED BY SINKING OF THE STEM. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. DOCTOR'S VIEW: SIZE MISMATCH. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9140346 ↗
• InjuryMar 11, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF CUP AND STEM, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2007, DOR: (B)(6) 2012, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Tissue Damage

  MAUDE report 8407341 ↗
• InjuryJan 16, 2019Corroded; Corroded

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 VIA THA. IT WAS REPORTED THAT THE PATIENT COMPLAINED PAIN FROM ABOUT 1 YEAR AGO AND IT HAD BEEN PROGRESSING ADDUCTION OF THE STEM DURING THE FOLLOW-UP OBSERVATION. THUS, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 BY REPLACING THE INSERT (P/N: 121887356), THE HEAD (P/N: 962712000), THE STEM (P/N: 900527210) WITH SLEEVE (P/N: 550501). THE CUP (MANUFACTURED BY KYOSERA) WAS NOT REPLACED, AND TWO ADDITIONAL SCREWS INSERTED. IT WAS CONFIRMED THAT ADHESION OF BLACK POWDER AT THE HEAD AND THE STEM NECK JOINT, DEGENERATION OF SOFT TISSUE, OSTEOLYSIS OF PROXIMAL PART OF FEMUR. THE STEM AND THE SLEEVE WERE STUCK TOGETHER AND DID NOT SEPARATE WHEN IT WAS EXPLANTED. THE SURGERY WAS COMPLETED WITHOUT PROBLEMS AND THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Osteolysis; Pain

  MAUDE report 8252305 ↗
• InjuryJun 12, 2018Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED (DATE OF THE PRIMARY SURGERY AND THE REVISION SURGERY WERE UNKNOWN) DUE TO SLEEVE LOOSENING. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7591612 ↗
• InjuryApr 10, 2018Disassembly; Disassembly

  SROM REVISION. SROM REVISION DUE TO DISLOCATION 5 YEARS AFTER INITIAL SURGERY. STEM DOES NOT SEEM TO HAVE ENGAGED WITH TAPER AND HAD COME LOOSE. SLEEVE WELL FIXED AND LEFT IN SITU. STEM WAS REVISED TO INCLUDE A 36 NECK OPTION AD POLY WAS EXCHANGED FOR A 36/52 NEUTRAL CUP WITH A 36 HEAD. PATIENT STABLE POST OP. RELEVANT PATIENT PRE-EXISTING CONDITIONS/ COMORBIDITIES: PREVIOUS DYSPLASTIC HIP WITH PELVIC OSTEOTOMY. DOI: 5 YEARS AGO; DOR: (B)(6) 2018 ; UNKNOWN HIP.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7410652 ↗