S-ROM ZTT 55-0514Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295175247), received between Oct 20, 2017 and Nov 18, 2025 — classified as 25 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (9 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS REVISED DUE TO PSEUDOTUMOR FORM METAL BEARING SURFACE. REVISION NOTES REPORTED OF SEVERE EROSIVE CHANGES AND EXTENSIVE SOFT TISSUE MASS CONSISTENT WITH PSEUDOTUMOR. THE ANTERIOR CAPSULE WAS INCISED WITH RELEASE EXTENSIVE AMOUNT OF BROWN DISCOLORED FLUID. THERE WAS ALSO SIGNIFICANT TENDINOSIS VISIBLE AND BONE EROSION. CLINICAL VISITS REPORTED OF PAIN, WEAKNESS, OSTEOLYSIS, AND BONE LOSS.

  Patient problems: Arthritis; Bone Notching; Fatigue; Hypersensitivity/Allergic reaction; Osteolysis; Pain; Pocket Erosion; Swelling/ Edema

  MAUDE report 23582037 ↗
• InjuryFeb 18, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR A PAINFUL LEFT HIP. THERE WAS A LOOSENING REPORTED AT THE STEM AND SLEEVE AT NON CEMENTED INTERFACE. DOI: (B)(6) 2019, DOR:(B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21400012 ↗
• InjuryJul 26, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2024. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO DISLOCATION, INSTABILITY, METAL WEAR, PAIN, IMPLANT LOOSENING, AND SUBSIDENCE -UNKNOWN IMPLANT(S). AT REVISION CORROSION WAS NOTED ON THE FEMORAL HEAD. DOI: (B)(6) 2007 DOE: (B)(6) 2024.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 19843263 ↗
• InjuryNov 2, 2023Osseointegration Problem; Osseointegration Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO OSTEOLYSIS AND ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2000 DATE OF REVISION: (B)(6) 2023 (LEFT HIP) TREATMENT: REVISION; HEAD, LINER AND CUP WERE REVISED DEPUY PRODUCTS USED: CATALOG ID: 550514 LOT NUMBER/PRODUCT IDENTIFIER: SB109322 COMPONENT TYPE: SLEEVE DESCRIPTION: SROM SLEEVE PROXIMAL TITANIUM 16D LG CATALOG ID: 560029 LOT NUMBER/PRODUCT IDENTIFIER: 686078 COMPONENT TYPE: HEAD DESCRIPTION: SROM HEAD ZIRCONIA 28MM +6 CATALOG ID: 563516 LOT NUMBER/PRODUCT IDENTIFIER: 604035 COMPONENT TYPE: STEM DESCRIPTION: SROM STEM STD 30MM +4L NECK 16MM X 11MM X 150MM COMPETITOR CUP, LINER, AND SCREWS WERE USED - WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 18054739 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4). THE EVENT REPORTED IN THIS PC OCCURRED AFTER THE 3RD REVISION SURGERY PERFORMED ON (B)(6) 2022. THIS PATIENT UNDERWENT THE INITIAL SURGERY ON (B)(6) 2015. THE 1ST REVISION SURGERY DUE TO LOOSENING OF IMPLANTS WAS PERFORMED ON (B)(6) 2021. THE 2ND REVISION SURGERY DUE TO INFECTION WAS PERFORMED ON (B)(6) 2021, WITH A CEMENT SPACER CONTAINING ANTIBIOTICS. THE 3RD REVISION SURGERY VIA THA WAS PERFORMED ON (B)(6) 2022. AFTER THE 3RD REVISION SURGERY, THE 4TH REVISION SURGERY DUE TO INFECTION WAS PERFORMED ON (B)(6) 2022. IN THE 4TH REVISION SURGERY, THE SURGEON IMPLANTED A NEW STEM, HEAD, LINER AFTER CURETTAGE AND DEBRIDEMENT WERE DONE. ZIMMER BIOMET¿S PRODUCT ON ACETABULAR AND OUR COMPANY¿S SLEEVE WERE KEPT USING AS THEY WERE. THE 4TH REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON COMMENTED THAT THE CAUSE OF THE INFECTION WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 14487754 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE IMPLANTS IN QUESTION. AFTER SURGERY, ON (B)(6) 2022, INFECTION WAS CONFIRMED. THE CAUSE OF INFECTION IS UNKNOWN. ON (B)(6) 2022, PATIENT UNDERWENT REMOVAL PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2007, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 14252976 ↗
• InjuryOct 4, 2021Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT BOTH STEM AND SLEEVE WERE LOOSE - UNDERSIZED. THE AFFECTED SIDE OF THE PATIENT WAS THE RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12573914 ↗
• InjuryJul 26, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT THE THA FOR LEFT HIP WITH THE STEM, SLEEVE, LINER AND HEAD IN QUESTION. A CUP AND 4 SCREWS WERE USED BUT THEY WERE MANUFACTURED BY OTHER COMPANY. ON (B)(6) 2021, THE REVISION SURGERY WILL BE PERFORMED BECAUSE THE STEM WAS VARUS AND LOOSENED OBVIOUSLY AND THE SLEEVE WAS LOOSENED, TOO. IN THE REVISION, THE IBG (IMPACTION BONE GRAFTING) WILL BE PERFORMED, AND THE STEM WILL BE REPLACED. THE SURGEON WANTS THE CUP TO BE LEFT. THE PRESENCE OR ABSENCE OF PAIN IN THE PATIENT AND THE MECHANISM OF ONSET ARE UNKNOWN. THE DETAILS ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THE STEM MIGHT HAVE BEEN INSERTED SLIGHTLY VARUS, AND THE ALIGNMENT OF THE CUP WOULD NOT BE SUCH A PROBLEM. SINCE THERE WAS NO LOOSENING IN THE CUP, IT WAS LEFT AS IT WAS, AND THE LINER WAS CHANGED FROM 28 MM TO 32 MM IN CONSIDERATION OF WEAR AND DISLOCATION RESISTANCE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12224933 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STEM ON RIGHT SIDE BECAME INFECTED AND SUBSIDED SUBSTANTIALLY AND LOOSENING OF THE UNKNOWN COMPONENT AT BONE TO IMPLANT INTERFACE. WE REMOVED FEMORAL AND ACETABULAR CONSTRUCTS AND REPLACED WITH PROSTALAC. DOI: (B)(6) 2018. DOR: (B)(6) 2020; RIGHT HIP.

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

  MAUDE report 11108271 ↗
• InjurySep 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 (MOM). IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED HASTILY ON (B)(6) 2020 BY REMOVING THE INSERT, THE STEM AND THE HEAD DUE TO ARMD AND INFECTION. THE REMOVAL SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT HE THOUGHT THAT THERE WAS A LITTLE SUSPICION OF THE CAUSAL RELATION BETWEEN ARMD AND INFECTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; No Code Available; Unspecified Infection

  MAUDE report 10514217 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THERE WAS NO REVISION REPORTED. PRIMARY SURGERY NOTES PROVIDED INDICATE THAT DURING PRIMARY SURGERY, THE PATIENT HAD A 1500 CC ESTIMATED BLOOD LOSS AND WAS GIVEN 2 UNITS OF PACKED RED BLOOD CELLS. DOI: (B)(6) 2007. DOR: NO REVISION REPORTED. (RIGHT HIP).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9437680 ↗
• InjuryOct 10, 2019Use of Device Problem; Loss of Osseointegration; Malposition of Device; Migration; Use of Device Problem; Loss of Osseointegration; Malposition of Device; Migration

  IT WAS REPORTED THAT THE SURGEON REPLACES THIS PATIENT¿S HIP APPROXIMATELY A YEAR OR SO AGO. THE PATIENT HAD NOTICED A CHANGE IN LEG LENGTH OVER TIME AND CAME IN FOR A FOLLOW UP APPOINTMENT AND XRAYS REVEALED THE SROM SLEEVE HAD SUBSIDED, LOOSENED AT BONE TO IMPLANT INTEFACE AND THE CONSTRUCT WENT INTO SLIGHT VARUS. THE SURGEON EXPLANTED THE SROM STEM, SLEEVE, AND HIP BALL AND IMPLANTED A ZIMMER STEM. THE ONLY LEGIBLE LOT # WAS RECORDED ON THE SLEEVE. THE LOT # OF THE STEM AND HEAD WERE NOT IDENTIFIED. DOI: A YEAR OR SO AGO; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9176154 ↗
• InjuryOct 3, 2019Naturally Worn; Naturally Worn

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE IMPLANT (P/N: UNKNOWN). THE PATIENT LIKELY HAD AN OSTEOLYSIS CAUSED BY SUSPECTED ARMD AT PELVIC BONE. THE SURGERY WAS COMPLETED, 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; Osteolysis; Pain

  MAUDE report 9151664 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS DISLOCATION, CLICKING, DISCOMFORT, BILATERAL LOWER EXTREMITY FOOT DROP, PAIN, ELEVATED BLOOD METAL IONS AND METAL ON METAL REACTION. PATIENT HAD STATED THAT SHE FELT THAT HER HIP HAS SUBLUXED AT TIMES. RANGE OF MOTION WAS NOTED TO BE LIMITED. THERE WAS TENDERNESS AND WEAKNESS AS WELL. INTRAOPERATIVE FINDINGS INCLUDE METALLOSIS WITH "DISH SOAP WATER FLUID", A SIGNIFICANTLY ABDUCTED ACETABULAR COMPONENT AND GROSS TRUNNIONOSIS ON THE FEMORAL HEAD. DURING THE REVISION SURGERY, PATIENT HAD ACUTE BLOOD LOSS ANEMIA SECONDARY TO THE SURGERY. TWO PACKED RED BLOOD CELLS WERE GIVEN. DOI: (B)(6) 2008. DOR: (B)(6) 2017, (RIGHT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage; Weakness

  MAUDE report 9110285 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE 1/30/15: DISC 209 PFS AND MEDICAL RECORDS RECEIVED. PFS IDENTIFIED PATIENT DOR, DOB, HEIGHT AND WEIGHT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. UPDATE AD 17 AUG 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEET RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION. UPDATED PATIENT'S INITIAL. ADDED LAWYER, SURGEON, HOSPITAL, PRODUCT DETAILS, NEW IP'S AND PATIENT HARM. DOI: (B)(6) 2002. DOR: (B)(6) 2003. (LEFT HIP).

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

  MAUDE report 9110134 ↗
• InjuryJun 4, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL COMPONENT. DOI: (B)(6) 2009. DOR: (B)(6) 2010; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8666233 ↗
• InjuryJun 3, 2019Loss of Osseointegration; Loss of Osseointegration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING, PAIN AND STIFFNESS. DOI: (B)(6) 2011. DOR: (B)(6) 2018 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8662605 ↗
• InjuryApr 25, 2019Loss of Osseointegration; Loss of Osseointegration

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES PATIENT SUFFERS FROM ELEVATED TOXIC COBALT CHROMIUM METAL DEBRIS. UPDATE PFS REPORTED DIFFICULT MOBILITY. UPDATE PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2009 - DOR: (B)(6) 2015 (LEFT HIP).

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; No Code Available

  MAUDE report 8552048 ↗
• InjuryApr 23, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES PATIENT SUFFERS FROM FAILURE OF THE HIP AND PAIN. UPDATE 30 AUG 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT "PREVI".

  Patient problems: Failure of Implant; Inadequate Osseointegration; No Code Available; Pain; Tissue Damage

  MAUDE report 8539409 ↗
• InjuryApr 4, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, A POPPING/SNAPPING SENSATION, AND LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE 12/12/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT'S MOST RECENT LAB RESULTS FROM 4/2014 INDICATED THE COBALT LEVEL WAS 0.6 ABD CHROMIUM LEVEL WAS <0.2. THE STEM ISN'T BEING REPORTED AT THIS TIME FOR THE HIGH METEL IONS. DURING THE PRIMARY OPERATION ((B)(6) 2005) A RETAINED DRILL BIT WAS REMOVED FROM A PREVIOUS OPERATION. THE MANUFACTUER OF THE DRILL BIT IS UNKNOWN AT THIS TIME. UPDATE AD 28 AUG 2018: RECEIPT OF DER. IT WAS REPORTED THAT THE DISTAL PORTION OF THE SROM STEM WAS BROKEN. STEM WAS WELL FIXED. THE DISTAL SPLINE OF THE STEM WAS REMOVED EASILY AFTER THE STEM WAS REMOVED. STEM HAS BEEN BROKEN SINCE 2015.

  Patient problems: Depression; Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain; Swelling

  MAUDE report 8482273 ↗
• InjuryApr 2, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2002 - DOR: (B)(6) 2010 (RIGHT HIP) FIRST REVISION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 8473708 ↗
• InjuryDec 19, 2018Fracture; Loss of Osseointegration; Osseointegration Problem; Fracture; Loss of Osseointegration; Osseointegration Problem

  CLAIM ALLEGES THAT PATIENT'S FEMORAL STEM FRACTURED. UPDATE 6/21/2012 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM SEVERE PAIN AND DISCOMFORT. UPDATE AD 06 JUL 2018: RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF STEM AND FRACTURE (COMPONENT). AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS A FAILED RIGHT TOTAL HIP REPLACEMENT. REVISION NOTES REPORTED THAT THE STEM IS BROKEN AND LOOSE.

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8179089 ↗
• InjuryApr 6, 2018Loss of Osseointegration; Loss of Osseointegration

  DER STATES THAT THE PATIENT HAD DISCOMFORT IN THE LEFT LEG WHILE WALKING FOR EXTENDED PERIODS OF TIME. SURGEON FOUND OUT THAT THE SLEEVE OF THE SROM STEM APPEARED TO BE LOOSE. SURGEON DECIDED THAT A RECLAIM REVISION STEM WOULD BE SUITABLE. IT WAS NOTED THAT THE LOOSENING INTERFACE WAS AT THE BONE TO IMPLANT. DOI: (B)(6) 2017; DOR: (B)(6) 2018: LEFT HIP.

  Patient problems: Discomfort; Inadequate Osseointegration; Not Applicable

  MAUDE report 7403447 ↗
• InjuryNov 27, 2017Malposition of Device; Malposition of Device

  PROCEDURE: REVISION RIGHT HIP. REVISION OF HIP PROSTHESIS DUE TO INCORRECT POSITIONING OF THE IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7058972 ↗
• InjuryOct 20, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF STEM AND SLEEVE. IT WAS ALSO REPORTED THAT THE SROM STEM WAS BROKEN. LOOSENING OCCURRED FROM BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Information

  MAUDE report 6965318 ↗