S-ROM ZTT 52-1483Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295170631), received between Nov 7, 2017 and Aug 8, 2025 — 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.

• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22751622 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT A THA SURGERY FOR OSTEOARTHRITIS OF THE HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT HAD A FRACTURE AND VISITED ANOTHER HOSPITAL. HOWEVER, THE PATIENT REFUSED REVISION SURGERY AND UNDERWENT CONSERVATIVE TREATMENT. AFTER THAT, THE PATIENT HAD PAIN. ON (B)(6) 2025, THE PATIENT WILL UNDERGO A REVISION THA.

  Patient problems: Limb Fracture; Pain

  MAUDE report 22060509 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PRIMARY SURGERY WAS PERFORMED VIA THA FOR OA ON HIP JOINT WITH THE IMPLANTS IN QUESTION. ON THE ACETABULAR SIDE, ZB'S CUP WAS USED. THE PATIENT HAD A GOOD POSTOPERATIVE COURSE, BUT HAD FEVER AND COMPLAINTS, AND THE INFECTION WAS CONFIRMED BY THE RESULTS OF EXAMINATION AFTER THE VISIT ON (B)(6) 2023. THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2023 TO REMOVE AND REPLACE THE IMPLANTS AND TO ADMINISTER THE ANTIBIOTICS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 17834951 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 17584268 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2007, THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS IN PAIN, AND OSTEOLYSIS AND LOOSENING WERE CONFIRMED. IT WAS INFERRED TO BE ARMD BECAUSE OF THE METAL LINER. THE CUP (POLO) WAS LOOSE AND THE NECK HEAD MATING AREA WAS BLACKENED. THE REVISION SURGERY WAS ON (B)(6) 2023, TO REMOVE THE CUP (POLO), THE STEM IN QUESTION AND THE HEAD IN QUESTION. IT WAS PERFORMED TO REPLACE TO THE CEMENT STEM. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2007. DOR: (B)(6) 2023. UNKNOWN HIP.

  Patient problems: Foreign Body Reaction; Osteolysis; Pain

  MAUDE report 16635399 ↗
• InjuryJul 14, 2021Degraded; Degraded

  LITIGATION RECORDS RECEIVED. LIGATION ALLEGES PERSONAL AND ECONOMIC INJURIES, ELEVATED COBALT AND CHROMIUM LEVELS, ADVERSE LOCAL TISSUE REACTION, PAIN, LOSS OF MOBILITY, ILLNESSES, PSEUDOTUMOR, AND INJURIES. NO LABS WERE PROVIDED FOR THE ALLEGED ELEVATED METAL IONS. OPERATIVE NOTES STATED THAT THERE WAS A LARGE EFFUSION, THERE WAS GRANULOMATOUS INFLAMMATION INVOLVING THE HIP CAPSULE. THE ABDUCTORS WERE ALIVE AND VIABLE. THERE WAS MILD OSTEOLYSIS AROUND THE PROXIMAL MEDIAL FEMUR. REVISION NOTES STATED THAT THE CAPSULE WAS PATULOUS AND EXPANDED. THERE WAS CORROSION BOTH AT THE TRUNNION AND ADAPTER SLEEVE. THE ACETABULAR COMPONENT WAS EASILY REMOVED WITHOUT BONE LOSS. WE INSPECTED THE OUTER SURFACE OF THE ACETABULAR COMPONENT. THERE WAS NO BONE ON GROWTH, ONLY FIBROUS MATERIAL PRESENT. THE PREVIOUS ACETABULAR COMPONENT WAS IN POOR POSITION AND PLACED WITH A HIGH HIP CENTER. DOI: (B)(6) 2009, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 12167175 ↗
• InjuryMay 14, 2020Loss of Osseointegration; Loss of Osseointegration

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP REPLACEMENT, ASEPTIC LOOSENING OF LEFT TOTAL HIP REPLACEMENT, AND FAILED METAL-ON-METAL TOTAL HIP ARTHROPLASTY. PATIENT WAS WITH A PAINFUL LEFT TOTAL HIP, WAS FOUND TO HAVE ASEPTIC LOOSENING OF HER LEFT FEMORAL STEM, AND WAS ALSO FOUND TO HAVE A METAL-ON-METAL TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES STATED THAT THE SHORT EXTERNAL ROTATORS WERE IDENTIFIED AND TAGGED FOR LATER REPAIR. THE FEMORAL STEM WAS GROSSLY LOOSE AND WAS ABLE TO MOVE IT BY HAND. THE S-ROM ZTT PROXIMAL SLEEVE AND STEM WERE WELL CONNECTED. THE HOOP EXTRACTOR WAS USED AND FOLLOWING REMOVAL OF LATERAL BONE WITH A HIGH-SPEED BUR, THE STEM WAS REMOVED WITHOUT ANY BONE LOSS. IT WAS GROSSLY LOOSE. REVERSE CURETTES WERE USED TO CLEAN THE PSEUDOMEMBRANE OUT THE FEMORAL CANAL. SCAR AND PSEUDOCAPSULE WAS DEBULKED. THE LEG LENGTHS WITH DISARTICULATION WERE RECREATED. THE PATIENT WAS SHORT PRIOR TO SURGERY FROM THE LOOSE SUBSIDED STEM. DOI: (B)(6) 2011. DOR: (B)(6) 2019; (LEFT HIP).

  Patient problems: Adhesion(s); Inadequate Osseointegration; No Code Available; Pain; Tissue Damage

  MAUDE report 10056620 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND PAIN. REVISION NOTES REPORTED SMALL AMOUNT OF CLOUDY SEROUS FLUID WITHIN THE BURSA AND DEEP TISSUES OF HIP CONSISTENT WITH SEROMA AND INFECTED SEROMA. PRIOR TO REVISION, THERE WAS NOTED SIGNIFICANT LOWER EXTREMITY EDEMA, SWELLING AND INABILITY TO AMBULATE. DOI: (B)(6) 2017 (HEAD & LINER); DOI: (B)(6) 2001 (CUP, STEM & SLEEVE); DOR: (B)(6) 2017 RIGHT HIP.

  Patient problems: Edema; No Code Available; Pain; Seroma; Unspecified Infection

  MAUDE report 9564554 ↗
• InjuryDec 4, 2019Fracture; Naturally Worn; Fracture; Naturally Worn

  PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED ON (B)(6) 2016. THE PFS INDICATED THE PATIENT WAS REVISED FOR DISLOCATION AND A FRACTURED STEM. THE STEM HAS ALREADY BEEN REPORTED ON (B)(4). PART/ LOT HASN'T BEEN PROVIDED AT THIS TIME. PPF HAS NO NEW ALLEGATIONS REPORTED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO PERFORM AN EXCISIONAL IRRIGATION AND DEBRIDEMENT AS WELL AS AN EXTENDED TROCHANTERIC OSTEOTOMY OF THE HIP TO ADDRESS DISLOCATION, EXTENSIVE METALLOSIS AND DAMAGED TRUNNION OF THE FEMORAL COMPONENT. UPDATED THE IMPLANT DATE OF THE HEAD AND THE DETAILS OF THE IMPACTED PRODUCTS. DOI: (B)(6) 2015 (HEAD), DOI: (B)(6) 2016 (LINER), DOR: (B)(6) 2016 (LEFT HIP).

  Patient problems: Bone Fracture(s); Foreign Body Reaction; Joint Disorder; No Code Available

  MAUDE report 9409781 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. DOI: (B)(6) 2008. DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Discomfort; No Code Available; Pain; Rash; Unspecified Infection

  MAUDE report 9086492 ↗
• InjuryAug 13, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED VIA THA (DATE OF PRIMARY SURGERY WAS UNKNOWN). IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE INSERT (P/N: 121887354), THE CUP (MANUFACTURED BY KYOCERA, P/N: 121782054), THE STEM (P/N: 900535210) WITH THE SLEEVE (P/N: 521483), THE HEAD (P/N: 962710000) DUE TO IMPLANTS ALIGNMENT ERROR, PAIN CAUSED BY LOOSEN. THE SURGERY WAS COMPLETED WITHOUT PROBLEM AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8889810 ↗
• InjuryMar 1, 2019Loss of Osseointegration; Loss of Osseointegration

  EMAIL NOTIFICATION RECEIVED CONTAINING PATIENT'S CLAIM. IT WAS REPORTED THAT THE PATIENT'S ASR IMPLANTS WERE REVISED TO ADDRESS LOOSENING. LOOSENING COMPONENT AND INTERFACE IS UNKNOWN. DOI: 2012, DOR: (B)(6) 2018: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8381362 ↗
• InjuryFeb 26, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2008 - DOR: (B)(6) 2010 (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Limited Mobility Of The Implanted Joint; Pain; Weakness

  MAUDE report 8369714 ↗
• InjuryJan 18, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGED LOOSENING OF STEM AFTER FIRST REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8261062 ↗
• InjuryDec 14, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES PAIN, DISCOMFORT, INFLAMMATION AND INFECTION CAUSED BY METALLOSIS. UPDATE REC¿D 2/7/2014 - PFS WAS RECEIVED FROM LEGAL, PRIMARY MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. UPDATE 02 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF STEM AND CUP, FRACTURE (BONE).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Pain; Unspecified Infection

  MAUDE report 8166421 ↗
• InjuryNov 9, 2018Failure to Osseointegrate; Unintended Movement; Failure to Osseointegrate; Unintended Movement

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8055901 ↗
• InjurySep 11, 2018Loss of Osseointegration; Loss of Osseointegration

  DR (B)(6) HOSPITAL (B)(6) 2018. ORIGINAL PRIMARY DATE UNKNOWN. 10.8.16 REVISION. ON (B)(6) 2018 REVISION FOR LOOSE FEMORAL COMPONENT. FEMUR RE REAMED AND REVISED TO LONG SROM STEM. FEMALE PATIENT INITIALS (B)(6). UNKNOWN JRN: 1 X 18X13 36+8 X 160 = DISCARDED; 1 X 18B SMALL SLEEVE = DISCARDED; 1 X 32+0 CERAMIC HEAD = DISCARDED.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7864629 ↗
• InjuryJul 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP AND INFECTION. DOI: (B)(6) 2007; DOR: NOT REPORTED; (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 7711102 ↗
• InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. LITIGATION PAPERS ALLEGE: ON (B)(6) 2008, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HER LEFT SIDE. AFTER A FEW WEEKS SHE BEGAN TO EXPERIENCE A CONSIDERABLE INCREASE IN THE LEVEL OF PAIN AND DISCOMFORT IN HER LEFT HIP. BY EARLY 2009, PATIENT'S LEFT HIP HAD BECOME EXTREMELY PAINFUL. ON (B)(6) 2009, PATIENT WAS REVISED. DOI: (B)(6) 2008; DOR: (B)(6) 2009; (LEFT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE: 10/24/2012: PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT. INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF PAIN AND POSSIBLE INFECTION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE 12/31/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REIMPLANTED ON (B)(6) 2009 AFTER ALL IMPLANTS WERE REMOVED ON (B)(6) 2009 FOR ALLEGED INFECTION. THE STEM AND SLEEVE IMPLANTED ON (B)(6) 2008 ARE BEING ADDED, BUT NOT REPORTED AS THEY WERE IMPLANTED MORE THAN 3 MONTHS. BEFORE THEY REMOVED ON (B)(6) 2009. LITIGATION CURRENTLY DOESN'T

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 7645661 ↗
• InjuryJan 19, 2018Malposition of Device; Malposition of Device

  THE REPORTED IMPLANTS WERE IMPLANTED TO PATIENT¿S HIP JOINT ON 2009 (DATE OF IMPLANT WAS UNKNOWN). IT WAS REPORTED THAT THE DISTAL SIDE OF THE STEM GOT CAUGHT IN THE CORTEX OUTSIDE OF THE FEMUR BECAUSE THE STEM WAS IMPLANTED IN VARUS DURING THE PRIMARY SURGERY. THE REVISION SURGERY WAS COMPLETED ON (B)(6) 2017. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL. DOI: 2009; DOR: (B)(6) 2017; UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 7205785 ↗
• InjuryJan 4, 2018Loss of Osseointegration; Loss of Osseointegration

  MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT TOTAL HIP REPLACEMENT AND TO RULE OUT ASEPTIC LOOSENING. OPERATIVE FINDINGS REPORTED THAT THE THERE WAS CONSISTENT ASEPTIC LOOSENING OF THE FEMORAL COMPONENT, PREVIOUS CERAMIC BALL WAS REMOVED WITHOUT SIGNIFICANT DIFFICULTY ALSO WITH THE PROSTHESIS ALONG WITH THE SLEEVE. IT WAS ALSO STATED THAT PATIENT HAS A HISTORY OF INSTABILITY. DOI: (B)(6) 2004; DOR: (B)(6) 2005; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 7164484 ↗
• InjuryNov 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS THIGH PAIN. / / INVESTIGATION METHOD: / / INVESTIGATION SUMMARY:

  Patient problems: Pain

  MAUDE report 7008490 ↗