S-ROM 55-6071Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295175919), received between Jun 28, 2017 and Mar 13, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (12 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT THA WITH THE PRODUCTS IN QUESTION. AFTER THE SURGERY, THE IMPLANTS WERE MOM AND ARMD WAS SUSPECTED. ON (B)(6) 2026, THE PATIENT UNDERWENT REVISION SURGERY FOR IMPLANTS REPLACEMENT. UPON INCISION, MILKY WHITE SYNOVIAL FLUID WAS OBSERVED, ALONG WITH DARK DISCOLORED SYNOVIAL MEMBRANE. THE CUP WAS COMPLETELY DISLODGED AND COULD BE EASILY REMOVED. AFTER REPLACING THE CUP WITH A COMPETITOR¿S IMPLANT, DELTA TS WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON BELIEVES THAT ARMD DUE TO MOM CAUSED THE CUP TO LOOSEN, RESULTING IN THE CUP DISLODGING DURING ACTIVITY.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Synovitis

  MAUDE report 24589600 ↗
• InjuryJul 22, 2025Osseointegration Problem; Osseointegration Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE CAUSE OF THE REVISION SURGERY. THIS PC REPORTS THE POOR FIT OF THE STEM FOUND DURING THE REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT AN INITIAL SURGERY PERFORMED WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2025, A FEMORAL HEAD DISLOCATION WAS CONFIRMED. ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED TO REPLACE THE LINER AND HEAD. DURING THE SURGERY, AN ACETABULAR CUP, POLO PRODUCT REPORTED ON (B)(4), LOOSENING WAS CONFIRMED AND THE CUP WAS REPLACED WITH A CEMENT CUP FROM OTHER COMPANY. WHEN THE HEAD WAS REPLACED WITH A NEW 9/10 TAPER HEAD, IT WAS FOUND THAT THE NECK TAPER WAS DISTORTED AND THERE WAS A POOR FIT, WHICH MAY HAVE BEEN THE CAUSE OF THE DISLOCATION, SO THE STEM WAS REMOVED AND REPLACED WITH A NEW CEMENTED STEM (C-STEM AMT). THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON CONCLUDED THAT THE REASON FOR THE CUP REVISION WAS THAT BLACK TISSUE HAD FORMED AT THE BOUNDARY SURFACE, WHICH HAD CAUSED BONE DISSOLUTION AND LOOSENING. THE REASON FOR THE STEM REVISION WAS THAT, JU

  Patient problems: Inadequate Osseointegration

  MAUDE report 22564678 ↗
• InjuryJul 22, 2025Osseointegration Problem; Osseointegration Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE CAUSE OF THE REVISION SURGERY. THIS PC REPORTS THE POOR FIT OF THE STEM FOUND DURING THE REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT AN INITIAL SURGERY PERFORMED WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2025, A FEMORAL HEAD DISLOCATION WAS CONFIRMED. ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED TO REPLACE THE LINER AND HEAD. DURING THE SURGERY, AN ACETABULAR CUP, POLO PRODUCT REPORTED ON (B)(4), LOOSENING WAS CONFIRMED AND THE CUP WAS REPLACED WITH A CEMENT CUP FROM OTHER COMPANY. WHEN THE HEAD WAS REPLACED WITH A NEW 9/10 TAPER HEAD, IT WAS FOUND THAT THE NECK TAPER WAS DISTORTED AND THERE WAS A POOR FIT, WHICH MAY HAVE BEEN THE CAUSE OF THE DISLOCATION, SO THE STEM WAS REMOVED AND REPLACED WITH A NEW CEMENTED STEM (C-STEM AMT). THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON CONCLUDED THAT THE REASON FOR THE CUP REVISION WAS THAT BLACK TISSUE HAD FORMED AT THE BOUNDARY SURFACE, WHICH HAD CAUSED BONE DISSOLUTION AND LOOSENING. THE REASON FOR THE STEM REVISION WAS THAT, JU

  Patient problems: Inadequate Osseointegration

  MAUDE report 22564512 ↗
• InjuryJul 22, 2025Osseointegration Problem; Osseointegration Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE CAUSE OF THE REVISION SURGERY. THIS PC REPORTS THE POOR FIT OF THE STEM FOUND DURING THE REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT AN INITIAL SURGERY PERFORMED WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2025, A FEMORAL HEAD DISLOCATION WAS CONFIRMED. ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED TO REPLACE THE LINER AND HEAD. DURING THE SURGERY, AN ACETABULAR CUP, POLO PRODUCT REPORTED ON (B)(4), LOOSENING WAS CONFIRMED AND THE CUP WAS REPLACED WITH A CEMENT CUP FROM OTHER COMPANY. WHEN THE HEAD WAS REPLACED WITH A NEW 9/10 TAPER HEAD, IT WAS FOUND THAT THE NECK TAPER WAS DISTORTED AND THERE WAS A POOR FIT, WHICH MAY HAVE BEEN THE CAUSE OF THE DISLOCATION, SO THE STEM WAS REMOVED AND REPLACED WITH A NEW CEMENTED STEM (C-STEM AMT). THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON CONCLUDED THAT THE REASON FOR THE CUP REVISION WAS THAT BLACK TISSUE HAD FORMED AT THE BOUNDARY SURFACE, WHICH HAD CAUSED BONE DISSOLUTION AND LOOSENING. THE REASON FOR THE STEM REVISION WAS THAT, JU

  Patient problems: Inadequate Osseointegration

  MAUDE report 22564354 ↗
• 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

  MAUDE report 15942368 ↗
• 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 15211104 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PATIENT COMPLAINTS OF PAIN. PAIN INHIBITED PATIENT'S ABILITY TO STAND. SEPARATION OF THE INTERDIGITATED PART OF THE STEM AND NECK OF IMPLANT WAS CONFIRMED. DOI: (B)(6) 2008. DOR: (B)(6) 2022.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 13562241 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PATIENT COMPLAINTS OF PAIN. PAIN INHIBITED PATIENT'S ABILITY TO STAND. SEPARATION OF THE INTERDIGITATED PART OF THE STEM AND NECK OF IMPLANT WAS CONFIRMED. DOI: (B)(6) 2008, DOR: 2/9/2022.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 13562203 ↗
• InjuryAug 6, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE CUP. DOI: (B)(6) 1997 ; DOR: (B)(6) 2000; (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12285827 ↗
• InjuryAug 6, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE CUP. DOI: (B)(6) 1997 ; DOR: (B)(6) 2000; (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12285823 ↗
• InjuryApr 22, 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 11705862 ↗
• 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 SENT 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 11700355 ↗
• 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 11589872 ↗
• 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 11589864 ↗
• InjuryDec 5, 2020Fracture; Osseointegration Problem; Fracture; 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)(4) 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 10951628 ↗
• 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 10162475 ↗
• 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 9603803 ↗
• 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 9603802 ↗
• 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 8739601 ↗
• 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 8739594 ↗
• InjuryJun 13, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008 BY USING AML VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE CUP (P/N: UNKNOWN), THE LINER (P/N: 121889148), THE HEAD (P/N: UNKNOWN) DUE TO SUSPECTED METAL ON METAL, SUPERIOR DISLOCATION OF THE CUP. THE SURGEON EXPLANTED THE CUP, AND MIXED ALLOGENEIC BONES, ARTIFICIAL BONES AND ANTIBIOTICS, TRANSPLANTED TO THE ACETABULAR HOLE, AND DID NOT USE A MESH. THERE WAS NO METALLOSIS NOR THE NECK HAD NOT DISCOLORATION IN BLACK. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8697368 ↗
• InjuryJun 13, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008 BY USING AML VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE CUP (P/N: UNKNOWN), THE LINER (P/N: 121889148), THE HEAD (P/N: UNKNOWN) DUE TO SUSPECTED METAL ON METAL, SUPERIOR DISLOCATION OF THE CUP. THE SURGEON EXPLANTED THE CUP, AND MIXED ALLOGENEIC BONES, ARTIFICIAL BONES AND ANTIBIOTICS, TRANSPLANTED TO THE ACETABULAR HOLE, AND DID NOT USE A MESH. THERE WAS NO METALLOSIS NOR THE NECK HAD NOT DISCOLORATION IN BLACK. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8697275 ↗
• InjuryJun 13, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008 BY USING AML VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE CUP (P/N: UNKNOWN), THE LINER (P/N: 121889148), THE HEAD (P/N: UNKNOWN) DUE TO SUSPECTED METAL ON METAL, SUPERIOR DISLOCATION OF THE CUP. THE SURGEON EXPLANTED THE CUP, AND MIXED ALLOGENEIC BONES, ARTIFICIAL BONES AND ANTIBIOTICS, TRANSPLANTED TO THE ACETABULAR HOLE, AND DID NOT USE A MESH. THERE WAS NO METALLOSIS NOR THE NECK HAD NOT DISCOLORATION IN BLACK. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8697274 ↗
• 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 8314848 ↗
• 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 8208654 ↗