S-ROM 1365-44-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295033790), received between Aug 3, 2017 and Aug 31, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that per surgeon the patient had elevated ion levels. Surgeon changed out the metal liner for polyethylene and a new head. Date of the original surgery is unknown, but believed to be in 2007 or 2008.DOI: Unknown.DOR: (b)(6) 2026.Affected side: Right hip.

  Patient problems: Metal Related Pathology

  MAUDE report 50531162 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED RIGHT HIP. INCISION AND DRAINAGE WERE PERFORMED, WITH SROM FEMORAL HEAD AND ZIMMER LINER EXCHANGE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22955003 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER WERE EXCHANGED DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6).2024 AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 20493478 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 17085693 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2009; DATE OF REVISION: (B)(6) 2023; (RIGHT HIP). TREATMENT: HEAD AND LINER WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16985803 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. HEAD AND POLY WERE SWAPPED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16952091 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW, THE PATIENT WAS REVISED DUE TO METALLOSIS OF THE RIGHT HIP. DURING THE PROCEDURE, THE SURGEON HAS TO TAKE DOWN THE GLUTEUS MAXIMUS TENDON BECAUSE OF THE SIGNIFICANT STIFFNESS IN THIS HIP. UPON ASSESSMENT OF THE TAPER, IT HAS MILD CORROSION SO IT HAS BEEN CLEANED OFF. ADDITIONALLY, THE ACETABULAR COMPONENT WAS SLIGHTLY UNDER ANTEVERTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Muscle/Tendon Damage; Muscular Rigidity; Osteolysis; Pain

  MAUDE report 12738742 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTES STATES ON (B)(6) 2021 THE PATIENT PRESENTS WITH PAIN WITH MRI FINDINGS OF OSTEOLYSIS AND FLUID COLLECTION. PLANS ARE MADE FOR REVISION DUE TO METALLOSIS. OPERATIVE NOTES PROVIDE THE DETAILS REGARDING THE (B)(6) 2021 REVISION OF THE RIGHT HIP. BROWNISH FLUID, PSEUDOTUMOR, TRUNNIONOSIS AND OSTEOLYSIS WITHIN THE GREATER TROCHANTER AND PROXIMAL FEMUR.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 12582567 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR A TOTAL KNEE AND ASKED ABOUT HIS METAL ON METAL HIP. UPON AN MRI THEY DETERMINED THAT HE HAD A BIT OF SCALLOPING OF THE TROCHANTER AND SOME LYRIC CHANGE. SURGEON DETERMINED IT BEST TO REMOVE THE METAL POLY AND SWAP OUT THE HEAD AS WELL. WHILE TRYING TO REMOVE THE METAL LINER THEY DAMAGED THE EXISTING CUP RIM WITH THE NEW METAL ON METAL DISIMPACTOR. THEY THEN DECIDED TO REMOVE THE CUP AND IMPLANT A NEW ONE BECAUSE OF THE DAMAGE. A POLY LINER, SECTOR CUP AND METAL HEAD WAS IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 12540989 ↗
• InjuryJun 7, 2021Adverse 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 AN UNSTABLE HIP. SURGEON EXPLANTED HEAD AND LINER REVISING WITH PINNACLE MDM. DOI: (B)(6) 2020; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11948321 ↗
• InjuryApr 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT JUMPED OFF A TRACTOR AND DISLOCATED HIP. DOI: (B)(6) 2018; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9963566 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT COMPLAINS OF PROGRESSIVE PAIN AND UNDERWENT A PRIOR REPORTED HEMATOMA DEBRIDEMENT FOR A SUSPECTED QUADRICEPS TEAR. THE PATIENT PRESENTED WITH A PSEUDOTUMOR AND CONCERN FOR METALOSIS FROM HIS METAL ON METAL HIP AND WAS THEN REVISED FOR LEFT TOTAL HIP METAL ON METAL WEAR WITH PSEUDOTUMOR. OPERATIVE NOTES REPORTED THAT THERE WAS A CONSIDERABLE AMOUNT OF HEMATOMA WAS IDENTIFIED. THE ABDUCTORS WERE ATTENUATED BUT NOT GROSSLY COMPROMISED. THE FEMORAL HEAD WAS REMOVED AND TRUNNIONOSIS WAS NOTED. INTRAOPERATIVE PATHOLOGY DOCUMENTED POSITIVE FROZEN SPECIMENS, WHICH WAS PRESENT IN THE TISSUE SENT AT THE BEGINNING OF THE CASE. PATHOLOGY REPORT NOT PROVIDED. DOI: (B)(6) 2007; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Foreign Body Reaction; Hematoma; Hypersensitivity/Allergic reaction; No Code Available; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 9865674 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS INSTABILITY. PATIENT HIP WAS LOOSE, SUBLUXED AND HAVE A SWOLLEN THIGH AND HEMATOMA. REVISION NOTES STATED THAT THE HEAD,LINER,CUP, AND STEM WERE REVISED. LEG WAS LONGER AT THE LEFT SIDE. DOI: (B)(6) 2009; DOR: (B)(6) 2009; (LEFT HIP).

  Patient problems: Hematoma; Joint Disorder; No Code Available; Swelling

  MAUDE report 9806702 ↗
• InjuryJan 16, 2020Naturally Worn; Naturally Worn

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. PATIENT COMPLAINTS OF PAIN, DISCOMFORT AND FOUND TO BE HAVING A LEG DISCREPANCY HAVING PATIENTS LEFT SIDE IS LONGER THAN THE RIGHT. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS METAL WEAR WITH PAIN. REVISION NOTES STATED, A SIGNIFICANT FLUID PUSHING OUT LITERALLY WAS NOTICED. THERE IS SIGNIFICANT HETEROTOPIC OSSIFICATION AS WELL AS SIGNIFICANT AREAS OF METALLIC DEBRIS. THERE WAS LYSIS AND EVIDENCE OF METAL DEBRIS UNDERNEATH THE TRUNNION. DOI: (B)(6) 2007; DOR: (B)(6) 2018; (LEFT HIP).

  Patient problems: Discomfort; Edema; No Code Available; Osteolysis; Pain

  MAUDE report 9596856 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM LETTER AND MEDICAL RECORDS RECEIVED. CLAIM LETTER ALLEGES PAIN, TENDINITIS, SCLEROTIC AROUND FEMUR SUGGESTIVE OF EFFECTIVE JOINT SPACE, PSEUDOTUMOR, MUSCLE SPRAIN, ELEVATED METAL IONS, METALOSIS, IMMOBILITY, STIFFNESS, INFLAMMATION MENTAL ANGUISH, FRUSTRATION, DEPRESSION, STIFFNESS AND EMOTIONAL DISTRESS. PATIENT IS SEEKING COMPENSATION FOR ALL THE DAMAGES. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS METALOSIS RESULTING TO PAIN, PSEUDOTUMOR, MUSCLE STRAIN, IMMOBILITY, SWELLING, NUMBNESS, AND INFLAMMATION. OPERATIVE NOTE REPORTED A LARGE INFLAMMATORY TISSUE CONSISTENT WITH A PSEUDOTUMOR. DOI: (B)(6) 2009 DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Hypoesthesia; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 9263127 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE PATIENT BEGAN TO EXPERIENCE PAIN AND DISCOMFORT. SURGEON BELIEVED SHE HAD OSTEOLYSIA AND ARMD. DURING REVISION ARMD, ALVAL, EFFUSION, AND OSTEOLYSIS WERE CONFIRMED. THE SURGEON WAS UNABLE TO DISSOCIATE THE LINER FROM THE CUP. AFTER 25 MINUTES HE DECIDED TO REVISE THE WHOLE CUP. THE STEM WAS NOTED TO BE STABLE.

  Patient problems: Discomfort; Edema; Foreign Body Reaction; No Code Available; Osteolysis; Pain

  MAUDE report 9186823 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN ASSOCIATED WITH METALLOSIS. DOI: (B)(6) 2007; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Foreign Body Reaction; No Code Available; Pain

  MAUDE report 8888152 ↗
• InjuryJun 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. PINNACLE CLAIM HAS NO ALLEGATION PROVIDED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO RIGHT HIP PROSTHETIC DISLOCATION RESULTING TO PAIN AND TO REPAIR TROCHANTERIC AVULSION. THIS IS A RECURRENT DISLOCATION DUE TO MECHANICAL COMPLICATIONS, THE FIRST DISLOCATION OCCURRED ON (B)(6) 2008 AND UNDERGONE CLOSED REDUCTION. OPERATIVE NOTE REPORTED TO HAVE NEAR COMPLETE AVULSION OF THE ABDUCTORS AT THE POSTERIOR TROCHANTER AND LINER HAD IMPINGEMENT ON SOFT TISSUE. ON (B)(6) 2009 RADIOLOGY REPORT DISLOCATION OF THE FEMORAL PROSTHESIS. BONE FRAGMENT IS PROJECTED OVER THE LATERAL ASPECT OF THE PROSTHETIC HEAD. DOI: (B)(6) 2008; DOR: (B)(6) 2009; RIGHT HIP.

  Patient problems: Joint Disorder; No Code Available; Pain

  MAUDE report 8704892 ↗
• InjuryJun 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN REPORTED THE PATIENT WAS EXPERIENCING PAIN IN THE RIGHT HIP.

  Patient problems: Foreign Body Reaction; Joint Dislocation; Joint Disorder; No Code Available; Pain

  MAUDE report 8682483 ↗
• InjuryMar 18, 2019Biocompatibility; Device Dislodged or Dislocated; Biocompatibility; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION AND ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2014 - DOR: (B)(6) 2015, (LEFT HIP), 2ND REVISION.

  Patient problems: Joint Dislocation; Test Result

  MAUDE report 8427894 ↗
• InjuryFeb 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES DISLOCATION. DOI: (B)(6) 2008, DOR: (B)(6) 2008, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8374002 ↗
• InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR, PULMONARY EMBOLISM, INFECTION AND ELEVATED METAL IONS AFTER FIRST REVISION.

  Patient problems: No Code Available; Pulmonary Embolism; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8264379 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DEALING WITH PAIN AND INSTABILITY AND WAS REVISED.

  Patient problems: No Code Available; Pain

  MAUDE report 8160102 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION IS REPORTED.

  Patient problems: No Code Available

  MAUDE report 8055913 ↗
• InjuryNov 6, 2018Corroded; Naturally Worn; Corroded; Naturally Worn

  LITIGATION PAPERS ALLEGE: WITHIN THE TWO YEARS AFTER SURGERY, CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND HIP AREA, AS WELL AS HIS GROIN. PATIENT ALSO EXPERIENCED EPISODES OF A GRINDING AND POPPING SENSATION IN HIS LEFT HIP. DOI: (B)(6) 2010 - DOR: NONE REPORTED (RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE AD 1 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. PPF HAS NO ALLEGATIONS AND NO REVISION REPORTED. THE UNKNOWN DEPUY PINNACLE HIP THAT WAS REPORTED IN THE WPC WAS CHANGED TO PINNACLE LINER. HEAD AND STEM WERE ADDED TO THE IMPACTED PRODUCT DUE TO A LARGE AMOUNT OF TOXIC COBALT CHROMIUM. THE RIGHT SIDE HIP THAT WAS REPORTED WAS CHANGED TO LEFT SIDE HIP. DOI: (B)(6) 2010 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8043020 ↗