MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 STD OFF; HIP FEMORAL STEM

Catalog Number	157001135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hemorrhage/Blood Loss/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Asr litigation record received.Litigation alleges asr alleges severe pain and discomfort, increased metal levels in blood including cobalt and chromium; permanent injuries, emotional distress, disability, disfigurement; economic damages.Doi: (b)(6) 2008; doe: (b)(6) 2022, right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Event or Problem Description
Medical records reports that the patient has a history of squeaking hip.There was extensive blackening of the tissue and metallosis.Patient's abductor tendons musculature and bones were well intact but the pseudocapsule was excised removing as much metallosis debris as possible.On (b)(6) 2022, the patient had a right total hip arthroplasty revision to address metallosis of the right hip.The indications for surgery included metal on metal hip with greatly elevated metal ions and squeaking hip.During the procedure, the surgeon observed blackening of the tissue and metallosis.The femoral stem was retained.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received.Patient sustain physical injuries to her tendons, ligaments, tissues and bones within her right hip.Patient suffered from pain, elevated cobalt and chromium levels and a pseudotumor.Surgeon informed that she needed revision.During the revision, metallosis throughout the hip was found.Post revision surgery, patient suffered a hip dislocation, blood loss and extreme pain.The anxiety about all the damage the high ions levels and metal in her bloodstream.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ7 STD OFF
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17404357
• Report Number: 1818910-2023-15299
• Device Sequence Number: 12543072
• Product Code: LPH
• UDI-Device Identifier: 10603295059387
• UDI-Public: 10603295059387
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 157001135
• Device Lot Number: CR4G11000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/16/2023; 10/09/2023; 12/11/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/17/2023; 10/11/2023; 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 158 KG