S-ROM 55-6072Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295175926), received between Jun 28, 2017 and Dec 12, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (5 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 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT A THA WITH THE CUP (NON-JJ PRODUCT) AND THE SCREW FOR HIP JOINT OA AT ANOTHER HOSPITAL. FOLLOWING PRODUCTS WERE USED FOR THE SURGERY. PINNACLE-A CUP (NON-JJ PRODUCT) PINNACLE METAL INSERT 36MMID 54MMOD SLEEVE SCREW 6.5X25 S-ROM STEM 30+4 ULTAMET 36MM HEADS +3. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, THE PATIENT FELL, AND IT WAS CONFIRMED THAT THE CUP WAS LOOSENING. AT FIRST, THERE WAS A POSSIBILITY THAT METAL-ON-METAL PSEUDOTUMOR OCCURRED DUE TO TRUNNIONOSIS. ON (B)(6) 2024, A THA REVISION SURGERY WAS PERFORMED. IT WAS CONFIRMED THAT THERE WAS NO METAL-ON-METAL PSEUDOTUMOR. THE SCREW WAS BROKEN. THE SURGEON GUESSED THAT THE CUP LOOSENED DUE TO EXTERNAL FORCE FROM FALL. THE CUP, LINER, AND STEM WERE REPLACED. THE S-ROM SLEEVE WAS NOT REPLACED. REMARKS: (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (NON-JJ PRODUCT): CUP. (B)(4) (SYNTHES): SCREW. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall; Foreign Body Reaction

  MAUDE report 20912796 ↗
• 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, WEAR OF THE SCREWS, ARMD, AND UNSPECIFIED SUBLUXATION OF THE STEM RESULTING IN JOINT INSTABILITY. DOI: (B)(6) 2008. DOR: (B)(6) 2022. UNKNOWN HIP.

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

  MAUDE report 15942323 ↗
• 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, WEAR OF THE SCREWS, 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 15942322 ↗
• InjuryJul 8, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE PINNACLE DEVICES AND THE S-ROM IN QUESTION. ON (B)(6) 2022, THE REVISION SURGERY WAS PERFORMED BECAUSE THE CUP HAS SHIFTED DUE TO ARMD. THE SURGEON LEFT THE SLEEVE AND REPLACED THE CUP WITH ZB¿S CUP. THE SURGEON ALSO REPLACED THE STEM AND THE HEAD. DOI: (B)(6) 2007, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Foreign Body Reaction

  MAUDE report 14957006 ↗
• InjuryDec 5, 2020Osseointegration Problem; Osseointegration Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008 VIA THA FOR THE PATIENT'S RIGHT HIP JOINT. POST-OPERATIVE PROGRESS WAS GOOD. IT WAS REPORTED THAT THE PATIENT HAD A PAIN AND INSENSITIVITY AT THE MOST RECENT REGULAR OUTPATIENT VISIT. THE SURGEON CHECKED BY X-RAY, HE FOUND BONE ATROPHY AT ACETABULAR SIDE AND FRACTURE AT FLOOR OF THE ACETABULUM. THERE WAS ALSO LOOSENING OF THE CUP (THE CUP WAS MANUFACTURED BY KYOCERA.). THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO LOOSENING OF THE CUP AND ARMD. THE SURGEON FOUND THAT THERE WAS BLACK POWDER AT HEAD-NECK JUNCTION, THE BREAKAGE OF THE SCREW (P/N: 556071), DEFORMATION AND DISCOLORATION OF THE JOINT CAPSULE. THE SURGEON REPLACED THE CUP, THE STEM AND THE HEAD. HE REMAINED THE SLEEVE AND BROKEN END OF THE SCREW IN THE BODY. HE REMAINED THE BROKEN SCREW BECAUSE HE COULD NOT REMOVE IT FROM THE BONE. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT THE CAUSE OF THIS EVENT WAS PROBLEMS WITH THE SLIDING SURFACE AND HEAD-NECK JUNCTION. THE SURGEON WILL KEEP THE PATIENT UNDER OBSERVATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Foreign Body Reaction; Inadequate Osseointegration; Pain

  MAUDE report 10951572 ↗
• InjuryJul 26, 2019Fracture; Fracture

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE CUP (MANUFACTURED BY KYOCERA, P/N: 121780046), THE LINER (P/N: 121889146), THE STEM (P/N: 900533210), THE HEAD (P/N: 962700100) DUE TO DISSOCIATION OF THE CUP, DISLOCATION CAUSED BY THE DISSOCIATION, BREAKAGE OF THE SCREW (P/N: 556072). IT WAS CONFIRMED AFTER SURGICAL INCISION THAT THE SCREW WAS BROKEN CAUSED BY DISSOCIATION, WEAR OF THE LINER AND THE TRUNNIONOSIS, PART OF THE SOFT TISSUE DISCOLORED TO BLACK, METALLOSIS. THE SURGERY WAS COMPLETED WITHOUT PROBLEMS, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; No Code Available; Tissue Damage

  MAUDE report 8833472 ↗
• InjuryJun 27, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2007 BY USING AML, PINNACLE VIA THA. IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL TO COMPLAIN THAT FELT SOMETHING WRONG WITH HER HIP JOINT AND FELT THE RANGE OF MOTION WAS ALSO WORSE THAN BEFORE. THUS, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE METAL LINER (P/N: 121889150) TO A POLY LINER, THE HEAD (P/N: UNKNOWN) TO A DELTA CERAMIC HEAD. THE SURGEON EXPLANTED THE METAL LINER, CRUSHED ARTIFICIAL BONES WITH A BONE MILL, TRANSPLANTED TO THE ACETABULAR HOLES, AND TIGHTENED A SCREW (P/N: UNKNOWN) OF A CUP WHICH WAS LOOSE AND INSERTED ONE ADDITIONAL SCREW. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. THE SURGEON CONSIDERED THAT THERE WAS SOME BONE REACTION, HOWEVER IT WAS UNLIKELY TO BE THE EFFECT OF METAL ON METAL. THE PATIENT HAD NO PAIN AND NO PROBLEM WITH BLOOD REACTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Loss of Range of Motion; No Code Available

  MAUDE report 8739597 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON BY REPLACING THE LINER AND THE HEAD DUE TO DULL PAIN IN AFFECTED AREA, FEMORAL NERVE PALSY, SUSPECTED ARMD.

  Patient problems: Nerve Damage; No Code Available; Pain; Tissue Damage

  MAUDE report 8314860 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON BY REPLACING THE LINER AND THE HEAD DUE TO DULL PAIN IN AFFECTED AREA, FEMORAL NERVE PALSY, SUSPECTED ARMD.

  Patient problems: Nerve Damage; No Code Available; Pain; Tissue Damage

  MAUDE report 8314859 ↗
• 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 8208657 ↗
• InjuryOct 26, 2017Use of Device Problem; Loss of Osseointegration; Use of Device Problem; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN, METAL CORROSION WAS SEEN AROUND THE JUNCTION PART AND CUP LOOSENING. COMPETITOR CUP WAS USED.

  Patient problems: Pain

  MAUDE report 6980491 ↗
• InjuryJun 28, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSE CUP DUE TO ARMD.

  Patient problems: Foreign Body Reaction

  MAUDE report 6673238 ↗
• InjuryJun 28, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSE CUP DUE TO ARMD.

  Patient problems: Foreign Body Reaction

  MAUDE report 6673225 ↗