S-ROM 56-3620Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295178231), received between Feb 14, 2014 and Apr 17, 2026 — classified as 60 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT WAS AN INFECTION CASE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24911155 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE FULLY REMOVED DUE TO INFECTION. SURGEON PUT IN AN ANTIBIOTIC SPACER TO ALLOW THE INFECTION TO HEAL AND THE SITE WAS CLEANED THOROUGHLY BEFORE PUTTING IN THE ANTIBIOTIC SPACER. DOI: (B)(6) 2020 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18493380 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2016, UNDERWENT REVISION OF HIS LEFT HIP DUE TO EXTREME HIP PAIN, GROIN PAIN, DISCOMFORT, AND CLICKING SENSATION POST OPERATIVELY. BLOOD TESTS REVEALED THAT COBALT FROM THE IMPLANT WAS SLOWLY SEEPING INTO HIS BLOOD STREAM AND RESULTED IN DANGEROUSLY HIGH LEVELS. THE ELEVATED COBALT LEVELS RESULTED IN VARIOUS HEALTH COMPLICATIONS SUCH AS HYPERTENSION, GENERALIZED ANXIETY, NERVOUSNESS AND DEPRESSION, FATIGUE, METAL TASTE IN HIS MOUTH, WEIGHT LOSS, FORGETFULNESS, PERIODIC ITCHING SENSATION ALL OVER HIS BODY, AMONG OTHER ISSUES WHICH ARE ATTRIBUTABLE TO THE COBALT POISONING. ON (B)(6) 2023. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED IN THE MEDICAL RECORDS, CLINICAL VISIT REPORTED ASSESSMENT MILD DEPRESSION, COBALT TOXICITY, FATIGUE AND ARTHRITIS. DOI: (B)(6) 2009, DOR: (B)(6) 2016, LEFT HIP.

  Patient problems: Anxiety; Depression; Discomfort; Fatigue; High Blood Pressure/ Hypertension; Itching Sensation; Metal Related Pathology; Necrosis; Pain; Swelling/ Edema

  MAUDE report 18064109 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL NOTIFICATION UPDATE INDICATES A REVISION WAS COMPLETED ON (B)(6) 2024 TO ADDRESS INFECTION. THE STEM, HEAD, LINER, AND CUP WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 16817075 ↗
• InjuryMar 16, 2023Degraded; Degraded

  MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED DUE TO THE FOLLOWING PATHOLOGIC FINDINGS: ALTR; CYST; JOINT EFFUSION; OSTEOLYSIS; CORROSION; FLUID COLLECTION; METALLOSIS; PSEUDOTUMOR; SYNOVITIS; DOI: (B)(6) 2010. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16553010 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW ECM RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT (B)(4). NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION ALLEGES THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT ON ACCOUNT OF HIS ASR HIP IMPLANT. LITIGATION FURTHER ALLEGES THAT THE PATIENT EXHIBITED SYMPTOMS OF A LOOSE IMPLANT. UPDATE 10/3/2012 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION, SIDE AND IMPLANT DATE. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE 12/23/2012 - ADDITIONAL LITIGATION PAPERS RECEIVED 11/30/2012 AND ATTACHED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE REC'D 1/19/2016: SUPPLEMENTAL INFO RECEIVED. A DOR WAS PROVIDED. THE TAPER SLEEVE IS BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 1/29/2016 UPDATE 1/21/16 MEDICAL RECORDS RECEIVED. CASE INFORMATION FORM AND COMPONENT STICKER SHEETS REVIEWED FOR MDR REPORTABILITY. REVISION SURGERY COMPONENT STICKER SHEET NOTED A BLOOD LOSS OF 825ML. THIS WILL BE ADDED TO PATIENT HARMS. THE C

  Patient problems: Adhesion(s); Anxiety; Depression; Discomfort; Foreign Body Reaction; Inflammation; Metal Related Pathology; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16131081 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW ECM RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT (B)(4). NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ PATIENT SEEKING LEGAL ACTION. UPDATE: 12/23/2012 - LITIGATION RECEIVED 11/30/2012. LITIGATION ALLEGES PATIENT HAD PAIN, PERMANENT PHYSICAL INJURIES AND DISFIGUREMENT AFTER ASR HIP IMPLANT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE REC'D 1/19/2016: SUPPLEMENTAL INFO RECIEVED. A DOR WAS RECEIVED. THE TAPER SLEEVE IS NOW BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 1/29/2016 UPDATE 1/21/16 MEDICAL RECORDS RECEIVED. CASE INFORMATION FORM AND COMPONENT STICKERS REVIEWED FOR MDR REPORTABILITY. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: FEB 12, 2016 UPDATE AD 10 SEP 2019. (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, EROSION AND LOSS OF THE SHORT EXTERNAL ROTATORS. OPERATIVE FINDINGS INCLUDE A DARKLY-HUED, BULGING BURSA FULL OF METAL DEBRIS, ABSENCE OF 50% OF THE INFE

  Patient problems: Adhesion(s); Anxiety; Depression; Foreign Body Reaction; Inflammation; Metal Related Pathology; Pain; Pocket Erosion; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16120756 ↗
• InjurySep 23, 2022Naturally Worn; Naturally Worn

  MEDICAL RECORDS RECEIVED AD (B)(6) 2022: AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO PAINFUL HIP, DISCOMFORT, SECONDARY TO METAL ON METAL WEAR. OPERATIVE NOTES INDICATED ELEVATED IONS HOWEVER THE RESULTS WERE BELOW NORMAL LEVEL AND MULTIPLE VAGUE COMPLAINTS. THERE WAS SOME METALLOSIS AT THE TRUNNION. THE ONLY AREA OF OBVIOUS METAL WEAR WAS ON THE TRUNNION. DOI: (B)(6) 2009, DOR: (B)(6) 2015, RIGHT HIP.

  Patient problems: Anxiety; Depression; Discomfort; Fatigue; Foreign Body Reaction; High Blood Pressure/ Hypertension; Itching Sensation; Metal Related Pathology; Pain

  MAUDE report 15469682 ↗
• InjuryAug 5, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT SHORTLY AFTER THE ORIGINAL SURGERY THE PATIENT HAD A HARD FALL. RECENTLY PATIENT CAME FOR FOLLOW-UP. SURGEON NOTICED THAT THE SROM STEM HAD ROTATED IN THE SLEEVE AND THEN LOCKED IN PLACE. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Fall

  MAUDE report 15173766 ↗
• InjuryJul 15, 2022Adverse 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) 2021. DATE OF REVISION: (B)(6) 2022. LEFT HIP. WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: Unspecified Infection

  MAUDE report 15033937 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION AND DRAINAGE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. DATE OF IMPLANTATION: (B)(6) 2013. DATE OF REVISION #1: (B)(6) 2013. DATE OF REVISION #2:(B)(6) 2015. DATE OF REVISION #3: (B)(6) 2021. DATE OF REVISION #4: (B)(6) 2021. DATE OF EVENT:(B)(6) 2022. (LEFT HIP) TREATMENT: AWAITING REVISION.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 14700148 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14565172 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION COMPLAINT RECEIVED AD 31 JAN 2022. LITIGATION RECORDS ALLEGES PAIN, INJURY ECONOMIC LOSS, PUNITIVE DAMAGES, EXCESSIVE LEVELS OF CHROMIUM AND COBALT. DOI: (B)(6) 2008, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Metal Related Pathology; Osteolysis; Pain; Pulmonary Embolism

  MAUDE report 13506098 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO METALLOSIS. DATE OF IMPLANT: (B)(6) 2009, DATE OF REVISION: (B)(6) 2021, (RIGHT HIP). TREATMENT: REVISION OF HEAD AND LINER.

  Patient problems: Cyst(s); Foreign Body Reaction; Osteolysis; Swelling/ Edema

  MAUDE report 12583091 ↗
• 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 12582566 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUESTION: 1. FOLLOW-UP FOR WHICH APEX HOLE ELIMINATOR(PRODUCT DETAILS) A. ''YOU HAVE PROVIDED US TWO DIFFERING APEX HOLE ELIMINATORS. AS IT IS NOT POSSIBLE FOR THE PATIENT TO HAVE HAD TWO OF THEM IMPLANTED, WHICH ONE WAS IN PLACE AT THE TIME OF THIS REVISION? ANSWER: THE ORIGINAL APEX HOLE ELIMATOR WAS PROBABLY DAMAGED OR STRIPPED SO A NEW ONE WAS REQUIRED ON (B)(6) 2013.

  Patient problems: Hematoma; Impaired Healing

  MAUDE report 12062886 ↗
• InjuryJun 17, 2021Degraded; Degraded

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL HIP TO ADDRESS METALLOSIS DATE OF IMPLANTATION: (B)(6) 2007. DATE OF REVISION: (B)(6) 2021 (LEFT HIP) LEADING UP TO THE REVISION OPERATION ON (B)(6) 2021, THE SURGEON NOTED ON EXAMINATION HE COULD HEAR A LITTLE RATCHETING WHEN THE PATIENT HYPERFLEXES. COBALT AND CHROMIUM LEVELS WERE 15 AND 2.5. UNIT OF MEASURE NOT GIVEN. MRI FINDINGS INDICATED A BIT OF AN ADVERSE REACTION TO METAL DEBRIS AS WELL AS A LITTLE BIT OF LYSIS. THE SURGEON INDICATED THE MAIN ISSUE WAS THE METAL DEBRIS WITHOUT SIGNIFICANT LYSIS. ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT HIP REVISION TO ADDRESS METALLOSIS, RATCHETING, AND INCREASED DISCOMFORT. THE SURGEON NOTED THERE WAS A LARGE RENT DIRECTLY POSTERIORLY IN THE CAPSULE. ALSO, THERE WAS MILD TAPER CORROSION THAT WAS CLEANED. THE ASR COMPONENTS WERE REVISED WITH A DEPUY GRIPTION SHELL, ALTRX POLYETHYLENE LINER, THREE DOME SCREWS, AND DEPUY COBALT CHROME HEAD. TREATMENT: REVISION OF THE ASR CUP, ASR FEMORAL HEAD, AND ASR FEMORAL SLEEVE; S-ROM FEMORAL STEM AND S-ROM PROXIMAL SLEEVE RETAINED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Foreign Body Reaction; Joint Laxity; Osteolysis

  MAUDE report 12016640 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT HAD A REVISION OF LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS WOUND BREAKDOWN WITH HEMATOMA AND DRAINAGE, RECURRENT INSTABILITY WITH DISLOCATION, AND COAGULOPATHY. THE INDICATIONS FOR SURGERY INCLUDED THAT THE PATIENT HAD A REVISION 6 WEEKS PRIOR (CAPTURED IN (B)(4)) TO ADDRESS A FAILED CONSTRAINED LINER AND MEDICAL RECORDS INDICATED THE PATIENT WAS HAVING PAIN.. THE PATIENT DISLOCATED AFTER THAT SURGERY AND NEEDED A REDUCTION. DURING THIS CURRENT PROCEDURE THE ACETABULAR AND FEMORAL COMPONENTS WERE REVISED. THE SURGEON REPORTED FINDING A COMPLETE FAILURE OF THE POSTERIOR SOFT TISSUE, AND REALLY NO LONGER ANY SOFT TISSUES PRESENT TO REPAIR. THERE WAS A SMALL AMOUNT OF HEMATOMA. HE WAS COAGULOPATHIC DURING THE CASE.

  Patient problems: Fluid Discharge; Hematoma; Joint Laxity; Pain; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11871940 ↗
• InjuryApr 28, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS ELEVATED METAL IONS. OPERATIVE NOTE REPORTED SCARRED FASCIA AND A SMALL AMOUNT OF CLEAR APPEARING SYNOVIAL FLUID. THERE WAS A SMALL AMOUNT OF DARK STAINING ON THE TRUNNION CONSISTENT WITH MILD CORROSION AND SCAR TISSUE. CLINICAL VISIT REPORTED ELEVATED METAL IONS 7.3, SOME TINNITUS, VISION LOSS, OCCASIONAL TIGHTNESS IN HIS CHEST, GROIN PAIN, PSEUDOTUMOR AND ASEPTIC LYMPHOCYTE PREDOMINANT VASCULITIS ASSOCIATED LESION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Inflammation; Metal Related Pathology; Pain; Scar Tissue; Swelling/ Edema; Tinnitus

  MAUDE report 11737163 ↗
• InjuryJan 18, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE NOTES (B)(6) 2020, INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REVISION DUE TO RIGHT HIP PAIN AND HIGH COBALT LEVELS. INTRA-OPERATIVE FINDINGS INCLUDE YELLOW TINGED EFFUSION, SYNOVITIS, TRUNNION CORROSION, BACK SIDED METAL LINER CORROSION AND METALLOSIS. METAL HEAD AND LINER WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain; Swelling/ Edema; Synovitis; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 11186573 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS RIGHT HIP PROSTHETIC INFECTION, METALLOSIS, PSEUDOTUMOR. REVISION NOTE STATED THAT COPIOUS PURULENCE WAS NOTED IN ADDITION TO METALLOSIS DEBRIS. ALL COMPONENTS WERE REMOVED. THE ACECTABULAR COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. DOI: (B)(6) 2008 - DOR: (B)(6) 2020, (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 11055143 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASSOCIATED STUDY: PINNACLE CUP, PINNACLE CUP. DATE OF EVALUATION: (B)(6) 2017. DATE OF ONSET: (B)(6) 2020. DIAGNOSIS: INFECTION. ADVERSE EVENT: INFECTION - SUPERFICIAL.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 9979135 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP SUTURE ABSCESS VS A REACTION VS DEEP HIP INVOLVEMENT : INFECTION - SUPERFICIAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT HIP). TREATMENT: LANCED AREA AND GROSS PUS WAS NOTED, PT PLACED ON KEFLEX 1 GRAM EVERY 8 HOURS TIMES 10 DAYS.

  Patient problems: Abscess; Discomfort; No Code Available; Unspecified Infection

  MAUDE report 9829894 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THERE WAS NO REVISION REPORTED. THE PATIENT WAS UNABLE TO UNDERGO REVISION AND IS NOW DECEASED. DATE OF DEATH OR REASON OF DEATH WAS NOT PROVIDED. CLINIC VISIT ON (B)(6) 2011 NOTES THAT THE PATIENT REPORTS PERSISTENT PAIN AND DISCOMFORT. PAST WORKUP INDICATES FLUID AND IRREGULARITY ON THE PATIENT'S RECENT MR SCAN. CLINIC VISIT ON (B)(6) 2011 INDICATES IMMOBILITY AND ELEVATED COBALT LEVEL AT 23.2 NG/ML (23.2 UG/L). PRIMARY SURGERY NOTES INDICATE THAT THE SLEEVE WAS LEFT SLIGHTLY PROUD UPON IMPACTION. DOI: (B)(6) 2007, DOR: NOT REVISED (LEFT HIP).

  Patient problems: Discomfort; Edema; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 9818225 ↗
• InjuryDec 6, 2019Corroded; Degraded; Naturally Worn; Corroded; Degraded; Naturally Worn

  PATIENT SEEKING LEGAL ACTION. UPDATE 3/22/16- PFS AND MEDICAL RECORDS RECEIVED. PFS REPORTED CONSTANT PAIN AND METALLOSIS. RADIOGRAPH RESULTS REPORTEDLY SHOWED HETEROTOPIC OSSIFICATION OF GREATER TROCHANTER AND METALLIC FRAGMENTS IN LEFT HIP. THERE IS NO REPORT OF REVISION OR REVISION SURGICAL REPORT WITHIN THE MEDICAL RECORDS AND PFS REPORTS ONLY DATES OF RIGHT HIP. HARMS UPDATED. UPDATE AD 14 NOV 2019: ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS SYMPTOMATIC MOM LEFT THA, RECALLED ASR COMPONENT, LARGE DIAMETER HEAD AND LEG LENGTH. OPERATIVE NOTE REPORTED HETEROTOPIC OSSIFICATION IN THE HIP JOINT, LARGE METAL HEAD AND ACETABULAR COMPONENT, FLUID IN THE HIP JOINT WHICH WAS TURBID BUT NOT VOLUMINOUS, PERI-CAPSULAR TISSUES AND CUP APPEARED GRAYISH IN COLOR. TRUNNION APPEARED TO BE MILD COLORATION CHANGES PERHAPS CONSISTENT WITH FRETTING WEAR. DOI: (B)(6) 2009 - DOR: (B)(6) 2018 (LEFT HIP).

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

  MAUDE report 9430113 ↗