S-ROM 55-6070Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295175902), received between Jan 2, 2019 and Dec 8, 2022 — classified as 13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2022Naturally Worn; Osseointegration Problem; Naturally Worn; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF A COMPETITOR CUP AND DEPUY SCREWS AT THE BONE TO IMPLANT INTERFACE, ARMD, AND UNSPECIFIED SUBLUXATION OF THE STEM RESULTING IN JOINT INSTABILITY. DOI: (B)(6) 2008, DOR: (B)(6) 2022, UNK HIP.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Joint Laxity

  MAUDE report 15942276 ↗
• 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 15211120 ↗
• 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 15211076 ↗
• InjuryApr 21, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PRIMARY SURGERY WAS PERFORMED VIA THA FOR RIGHT HIP WITH THE IMPLANTS. ON (B)(6) 2021, THE REVISION SURGERY WAS PERFORMED BECAUSE THE CUP FIXATION WAS LOST AND THE ACETABULAR WAS HARDLY DAMAGED. IN THE REVISION, IT WAS FOUND THAT THE CORROSION AT THE NECK HAD OCCURRED AND THERE WAS PSEUDOTUMOR DUE TO THIS CORROSION. THE SURGEON COULDN¿T REMOVE THE STEM AND IT WAS LEFT IN THE PATIENT. HE REMOVED THE HEAD, INSERT AND CUP (OTHER COMPANY'S PRODUCT). THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT IS REHABILITATING OF WALKING TRAINING. THE SURGEON COMMENTED THAT THE PSEUDOTUMOR WAS CAUSED BY THE WEAR BETWEEN INSERT AND HEAD, AND THE CORROSION BETWEEN THE STEM AND HEAD. WE WENT ATTENTION TO THE SALES REP TO COMPLY WITH THE PRESCRIBED REPORTING DATE. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2009; DOR: (B)(6) 2021 ; RIGHT HIP.

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

  MAUDE report 11701513 ↗
• InjuryApr 21, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PRIMARY SURGERY WAS PERFORMED VIA THA FOR RIGHT HIP WITH THE IMPLANTS. ON (B)(6) 2021, THE REVISION SURGERY WAS PERFORMED BECAUSE THE CUP FIXATION WAS LOST AND THE ACETABULAR WAS HARDLY DAMAGED. IN THE REVISION, IT WAS FOUND THAT THE CORROSION AT THE NECK HAD OCCURRED AND THERE WAS PSEUDOTUMOR DUE TO THIS CORROSION. THE SURGEON COULDN¿T REMOVE THE STEM AND IT WAS LEFT IN THE PATIENT. HE REMOVED THE HEAD, INSERT AND CUP (OTHER COMPANY'S PRODUCT). THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT IS REHABILITATING OF WALKING TRAINING. THE SURGEON COMMENTED THAT THE PSEUDOTUMOR WAS CAUSED BY THE WEAR BETWEEN INSERT AND HEAD, AND THE CORROSION BETWEEN THE STEM AND HEAD. WE WENT ATTENTION TO THE SALES REP TO COMPLY WITH THE PRESCRIBED REPORTING DATE. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2009: DOR: (B)(6) 2021 ; RIGHT HIP.

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

  MAUDE report 11700358 ↗
• InjuryMar 30, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT RECEIVED A PRIMARY THA UTILIZING A COMPETITOR CUP, DEPUY SCREWS, HEAD, LINER, AND STEM. THE PATIENT RECEIVED A COMPETITOR CUP REVISION SECONDARY TO LOOSENING OF THE CUP AND SCREWS. THE STEM WAS RETAINED. THE PATIENT WAS REVISED WITH A COMPETITOR CUP AND LINER WITH A DEPUY FEMORAL HEAD. DOI: (B)(6) 2008, DOR: (B)(6) 2021, UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11589850 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2007. IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020 DUE TO PAIN. THERE WAS SUSPICION OF ARMD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 10162478 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2007. IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020 DUE TO PAIN. THERE WAS SUSPICION OF ARMD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 10162476 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2007. IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020 DUE TO PAIN. THERE WAS SUSPICION OF ARMD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 10162470 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009 VIA THA. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED BY EXPLANTING THE CUP (MANUFACTURED BY KYOCERA, P/N: 121780056, LOT#: 00277), THE LINER (P/N: 121887356), THE HEAD (P/N: 962712000) DUE TO SUSPECTED INFECTION CAUSED BY PAIN, AND INDWELLED CEMENT SPACER MOLDS (DATE OF SURGERY WAS UNKNOWN). THE STEM (P/N: 961315000) WAS RETAINED AT THIS TIME, AND THE REVISION SURGERY WAS SCHEDULED TO BE PERFORMED ABOUT 3 MONTHS LATER BY EXPLANTING THE STEM AND IMPLANTING IMPLANTS AFTER CONFIRMING SEDATION OF INFECTION (DATE OF SURGERY WAS NOT FIXED YET). THE STEM IS PLANNING TO BE RETURNED AFTER THE REVISION SURGERY HAS BEEN PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 9686862 ↗
• InjuryJan 17, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2007 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REMOVING PSEUDOTUMOR TISSUE, WASHING OUT, AND REPLACING THE CUP (MANUFACTURED BY KYOCERA, P/N: 121780054, LOT #: 00029) WITH 3 SCREWS (P/N: UNKNOWN), THE LINER (P/N: 121887354), THE HEAD (P/N: 962710000) DUE TO PAIN, LOOSENING CUP, PSEUDOTUMOR. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9603799 ↗
• InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND SWELLING.

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 8264280 ↗
• InjuryJan 2, 2019Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  IT WAS REPORTED THAT THE SURGEON RECOGNIZED DISLOCATION OF THE CUP ON THE PATIENT¿S HIP JOINT UNDER X-RAY. THUS, THE REVISION SURGERY WAS PERFORMED BY REPLACING THE CUP, THE INSERT, THE STEM, THE HEAD.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8208710 ↗