S-ROM 56-3516Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295178194), received between Nov 2, 2017 and Feb 7, 2024 — classified as 29 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2024Adverse 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 SIGNIFICANT PAIN IN THE LEFT HIP. METAL ION LEVELS WERE PERFORMED AND IT SHOWED SLIGHTLY ELEVATED METAL ION. DOI: (B)(6) 2004, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP. THIS PC IS BILATERAL LINKED WITH (B)(4) RIGHT HIP ARTHROPLASTY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18658965 ↗
• 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 18054744 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED HIP AND LOOSENING OF CUP AT BONE TO IMPLANT INTERFACE. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14113613 ↗
• InjuryDec 14, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED AND STATED THE FOLLOWING: THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, METALLOSIS, ELEVATED METAL IONS, PAIN, CREPITUS IN THE HIP. OPERATIVE NOTE REPORTED THERE WAS A GROSS EGRESS OF CLOUDY FLUID CONSISTENT WITH METALLOSIS, LARGE DEFECT OF THE CAPSULE AND EXTERNAL ROTATORS. THE ABDUCTOR WERE COMPLETELY NECROTIC AND BONE WAS GRAY AND NECROTIC. THERE WAS CORROSION IN THE FEMORAL HEAD AND TRUNNION, EXTENSIVE SOFT TISSUE MUSCULAR DAMAGE. DOI: ON (B)(6) 2008, DOR: ON (B)(6) 2021, LEFT HIP.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Deformity/ Disfigurement; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Necrosis; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 13005200 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 12565124 ↗
• InjuryMay 4, 2021Migration; Migration

  IT WAS REPORTED THAT DR PERFORMED THE PATIENTS INITIAL SURGERY ON (B)(6) 2009. PATIENT WAS COMPLAINING OF SOME THIGH PAINS. WHEN LOOKING AT THE X-RAY, DR K NOTICED THAT STEM APPEARED TO HAVE SHIFTED INTO VARUS. HE DECIDED THIS COULD BE THE CAUSE FOR HER DISCOMFORT AND FELT SHE WOULD BENEFIT FROM A REMOVAL OF THE SROM STEM. THE FEMORAL HEAD AND STEM WERE REMOVED AS WELL AS THE ACETABULAR LINER. HE IMPLANTED A COMPETITOR STEM WITH THEIR 32MM HEAD. A NEW LINER WAS IMPLANTED FOR THE PINNACLE CUP AND A TRIAL REDUCTION WAS PERFORMED. HIP WAS FOUND TO BE STABLE AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2009; DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Discomfort; Pain

  MAUDE report 11771336 ↗
• InjuryApr 15, 2021Use of Device Problem; Use of Device Problem

  ON (B)(6) 2000, THE PATIENT HAD A RIGHT PRESS-FIT ARTHROPLASTY TO ADDRESS PAIN, DISCOMFORT AND STIFFNESS SECONDARY TO OSTEOARTHRITITS/LABRAL CALCIFICATION. DEPUY COMPONENTS, INCLUDING SROM STEM/SLEEVE WERE USED DURING THIS PROCEDURE. TWO SCREWS WERE PLACED. MEDICAL RECORDS FROM (B)(6) 2021 NOTE THE PATIENT HAS BEEN EXPERIENCING RIGHT HIP INSTABILITY. ON (B)(6) 2021, THE PATIENT HAD A REVISION RIGHT TOTAL HIP TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY, SECONDARY TO ECCENTRIC POLYWEAR WITH POLYETHYLENE SYNOVITIS AND RECURRENT SUBLUXATION. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE. THE INDICATIONS FOR SURGERY INCLUDED PAIN AND ¿PROBABLY HAS SOME IMPINGEMENT WITH SECONDARY POLY WEAR.¿ THE SURGEON REPORTED FINDING ECCENTRIC POLYWEAR, WITH SYNOVITIS. THE STEM AND CUP HAD LESS THAN OPTIMAL ANTEVERSION AND WERE REVISED. A CYST WAS NOTED IN THE ILIOPSOAS TENDON SHEATH AND WAS DEBRIDED. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2000, DATE OF REVISION: (B)(6) 2021, (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Joint Laxity; Pain; Synovitis

  MAUDE report 11676051 ↗
• InjuryApr 1, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. AFTER LOOKING AT X-RAY AND MRI, THE SURGEON SAW THAT THE STEM MAY BE LOOSE. ONCE WE GOT IN THE OR, THE STEM WAS VERY DIFFICULT TO SEPARATE THE STEM FROM THE SLEEVE, THE SURGEON HAD TO USE A METAL CUTTING BURR TO GET IT TO SEPARATE. AFTER STEM AND SLEEVE WERE REMOVED, HE REPLACED WITH A RECLAIM MODULAR STEM. DOI: (B)(6) 2018; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11601834 ↗
• InjuryMar 31, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. THE SURGEON PERFORMED PATIENT'S INITIAL SURGERY IN (B)(6) 2020. THE PATIENT WAS IMPLANTED WITH A COMPETITOR ACETABULAR COMPONENT AND AUGMENT, BUT AN SROM STEM AND FEMORAL HEAD. THE STEM WAS UNFORTUNATELY LOOSE AND NEEDED TO BE REMOVED. DR. HAD TO PERFORM A FEMORAL SHORTENING IN THE PATIENT'S INITIAL SURGERY. UNFORTUNATELY, THE STEM DID NOT TAKE TO THIS PROCEDURE AND APPEARED TO BE LOOSE. WHAT REMAINED OF THE PATIENT'S PROXIMAL FEMUR WAS NOT IN THE BEST CONDITION EITHER, SO AFTER REMOVING THE SROM STEM AND SLEEVE, DR. OPTED TO PERFORM A PROXIMAL FEMORAL REPLACEMENT. DOI: (B)(6) 2020. DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11595398 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR HAS UNFORTUNATELY HAD TO PERFORM SEVERAL REVISIONS WITH THIS PATIENT. THE ONLY ONE I WAS ABLE TO PULL UP RECORDS FOR WAS THE MOST PREVIOUS REVISION DONE IN (B)(6) 2020. THIS PATIENT SUFFERS FROM EHLERS DANLOS SYNDROME. DR HAD AN SROM STEM AND 22MM HEAD IN, WITH A COMPETITOR ACETABULAR COMPONENT. THE PATIENT WAS FEELING SOME IMPINGING OF THEIR HIP, SO DR (B)(6) OPTED TO CHANGE OUT THE COMPETITOR LINER, AS WELL AS THE SROM STEM AND HEAD. A 16 X 11 X 150 30+4 STEM WAS REMOVED AND A 16 X 11 X 150 36 +6 WAS IMPLANTED. THE SROM SLEEVE WAS LEFT ALONE. A TRIAL REDUCTION WAS PERFORMED WITH A 36MM +0 HEAD AND FOUND TO BE STABLE. DR BELIEVED THE ADDITIONAL OFFSET HELPED WITH THE PATIENTS IMPINGING ON THEIR ACETABULAR COMPONENT. THE REAL 36MM +0 CERAMIC HEAD WAS OPENED AND IMPLANTED. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT HIP.

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

  MAUDE report 11201609 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2002, THE PATIENT RECEIVED A RIGHT PINNACLE/SROM MOM TO TREAT PAIN AND DYSFUNCTION SECONDARY TO OSTEOARTHRITIS. INTRAOPERATIVELY, THE SURGEON NOTES THERE WAS FEMORAL HEAD ARTHROSIS, MILD SYNOVITIS, AND SIGNIFICANT CALCIFICATION OF THE LABRUM. THE PATIENT RECEIVED A PINNACLE CUP, METAL ULTAMET LINER, COCR HEAD, ZTT SLEEVE, AND SROM STEM. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. CLINIC NOTE DATED (B)(6) 2020, INDICATED THAT THE PATIENT PRESENTED WITH RIGHT HIP PAIN. RADIOLOGY REPORTS REVEALED THAT THE CUP WAS VERTICAL. THE SURGEON SUSPECTED METALLOSIS AND SCHEDULED THE PATIENT FOR A REVISION OF THE RIGHT HIP. ON (B)(6) 2020, THE PATIENT RECEIVED A TOTAL REVISION OF THE RIGHT HIP TO TREAT PAIN SECONDARY TO SUSPECTED ARMD. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED SCAR TISSUE AND A PSEUDOCYST. THE CUP WAS WELL-FIXED BUT VERTICAL, AND REVISED. THE STEM AND SLEEVE WERE WELL-FIXED BUT REVISED. THERE WAS NO WEAR IDENTIFIED ON THE REVISED METAL LINER. THE HEAD HAD SOME TRUNNIONOSIS, BUT NO EVIDENCE OF WEAR, AND WAS REVISED. THE SURGEON NOTED THAT THERE WAS NO METALLOSIS IN THE JOINT AND NO PSEUDOTUMOR PRESENT. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS

  Patient problems: Adhesion(s); Cyst(s); Foreign Body Reaction; No Code Available; Pain

  MAUDE report 10600883 ↗
• InjuryJul 19, 2019Loss of Osseointegration; Loss of Osseointegration

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED VIA CD SHIPMENT LAST 04 APR 2019. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A PAINFUL AND LOOSE FEMORAL COMPONENT. THERE WAS A LOT OF SCAR TISSUE WHICH MADE REMOVAL OF THE STEM DIFFICULT. THE STEM WAS FOUND OUT TO BE ONLY FIXED ON THE PROXIMAL END. THE FEMUR CRACKED AND WAS BROKEN RIGHT WHEN THE SURGEON WAS ATTEMPTING TO DETERMINE THE FINAL LENGTH ON THE FEMORAL CUP AFTER ADDING THE NON-DEPUY REVISION STEM. THE FRACTURE WAS NOTED TO BE SHORT. CABLES WERE PLACED AROUND THE FEMUR. DOI: (B)(6) 2010 - DOR: (B)(6) 2013, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain; Scar Tissue

  MAUDE report 8808830 ↗
• 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 8473642 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES FRACTURE (COMPONENT), METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2005 - DOR: (B)(6) 2017, (LEFT HIP).

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8378429 ↗
• InjuryFeb 27, 2019Fracture; Biocompatibility; Fracture; Biocompatibility

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR, METALLOSIS, ELEVATED METAL IONS AND FRACTURE (COMPONENT).

  Patient problems: Deformity/ Disfigurement; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8373414 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION AND ELEVATED METAL IONS. DOI: (B)(6) 2009. DOR: (B)(6) 2010 (2ND REVISION); LEFT HIP.

  Patient problems: No Code Available; Test Result; Unspecified Infection

  MAUDE report 8365985 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR AND INFECTION. DOI: (B)(6) 2006 - DOR: (B)(6) 2013 (LEFT HIP).

  Patient problems: Discomfort; Loss of Range of Motion; Osteolysis; Pain; Swelling; Tissue Damage; Unspecified Infection

  MAUDE report 8319787 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PENDING PRODUCT LIABILITY REPORTS: LITIGATION ALLEGED FRICTION AND WEAR BETWEEN THE METAL HEAD AND LINER CAUSED THE RELEASE OF TOXIC METAL IONS AND PARTICLES INTO THE PATIENT'S BLOOD. AS A RESULT, PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT, AND INFLAMMATION. PATIENT ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HER HIP-JOINT WHEN WALKING OR MOVING TO AND FROM SITTING POSITION. THE ORIGINAL PROCEDURE INVOLVED THE RIGHT HIP. THE IMPLANT DATE WAS (B)(6) 2005. NO REVISION PROCEDURE HAS BEEN REPORTED.

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8306735 ↗
• InjuryJan 15, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: No Code Available; Synovitis; Test Result

  MAUDE report 8247599 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN, DISCOMFORT, AND METAL REACTIVE DISEASE. PPF ALLEGES ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT THA. REVISION NOTES REPORTED METAL REACTION WITH SYNOVITIS IN THE HIP. MRI SHOWED SOME DEGENERATIVE CHANGES. DOI: (B)(6) 2007 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; No Code Available; Pain; Test Result

  MAUDE report 8178419 ↗
• InjuryNov 15, 2018Loss of or Failure to Bond; Osseointegration Problem; Loss of or Failure to Bond; Osseointegration Problem

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. UPDATE 10/25/2012- LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE AD 15 MAY 2018: THE RECEIPT OF PPF AND STICKER SHEETS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP, FRACTURE (COMPONENT), DISLOCATION WITH OPEN REDUCTION, AND LOOSENING OF STEM. IT WAS INDICATED IN THE REVISION STICKER SHEETS THAT THE CUP AND LINER WERE REMOVED ON (B)(6) 2011.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8073394 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION REQUIRING IV ANTIBIOTICS AFTER FIRST REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 8047837 ↗
• InjurySep 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON REMOVED ALL IMPLANTS AND PLACED A PROSTALAC PROSTHESIS. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7850799 ↗
• InjuryAug 14, 2018Loss of or Failure to Bond; Loss of Osseointegration; Loss of or Failure to Bond; Loss of Osseointegration

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT.- PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE SROM SLEEVE. DOI: (B)(6) 2006 - DOR: (B)(6) 2012 (RIGHT HIP). UPDATE - (B)(6) 2012 - LITIGATION PAPERS RECEIVED. THEY ALLEGE THAT THE PATIENT SUFFERS FROM SEVERE PAIN, DISCOMFORT, SWELLING, AND DIFFICULTY SLEEPING. AN INVOICE WAS LOCATED AND THE PART/LOT INFORMATION WAS ADDED FOR THE METAL LINER AND FEMORAL HEAD. INITIAL EMDRS WERE CREATED. UPDATE - (B)(6) 2012 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED THE PATIENT'S NAME, "(B)(6)". THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD (B)(6) 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF STEM. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR

  Patient problems: Discomfort; Inadequate Osseointegration; Pain; Swelling

  MAUDE report 7783028 ↗
• InjuryAug 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS POSTERIOR LIP POLY WEAR. DOI: (B)(6) 2004; DOR: (B)(6)2011; (RIGHT HIP). UPDATE (B)(6) 2012- LITIGATION PAPERS RECEIVED. LITIGATION PROVIDED GENERAL PINNACLE METAL ON METAL INFORMATION AND PROVIDED NO SPECIFIC PATIENT INFORMATION. DUE TO THE MENTIONING OF METAL ON METAL, WE ARE ADDING THE FEMORAL HEAD.

  Patient problems: Not Applicable

  MAUDE report 7781194 ↗