MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Failure of metal-on-metal total hip arthroplasty mimicking hip infection¿ by mark m.Mikhael et al.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An article ¿failure of metal-on-metal total hip arthroplasty mimicking hip infection¿ by mark m.Mikhael et al reports two patients with failure of metal-on-metal implants who presented with signs that mimicked a deep-seated hip infection.Although the two cases were similar in terms of the clinical presentation, each ultimately represented a different pathological condition and etiology.A (b)(6)-year-old male (case 2) reported pain in left hip after undergoing a left metal on metal total hip arthroplasty having asr xl acetabular component with a cobalt-chromium metal bearing surface (depuy).He had a severe limp due to the pain, and occasional squeaking noise along with metal allergy.Physical examination demonstrated a severely antalgic gait.He had a well-healed surgical incision but notable swelling, induration around the left hip.Radiographs of the left hip revealed a well-seated, uncemented, metal-on-metal total hip prosthesis.The levels of inflammatory biomarkers were elevated.Gross intraoperative examination revealed extensively necrotic tissue and a metallosis reaction.Lateral radiograph revealed a mismatch between a larger femoral head component (55 mm) and a slightly smaller acetabular component (60 mm outer diameter).The authors believe that the patient had extreme metal wear secondary to equatorial contact between the femoral head and acetabular components.A highly cross-linked polyethylene bearing surface was implanted.The postoperative course was complicated by wound dehiscence in the left hip, which required evacuation of a hematoma and revision of the wound approximately two weeks after the procedure.At 3 months postoperatively, the patient was symptom-free.Asr xl hip implant was involved with the above adverse events.Impacted products asr xl hip implant.

Manufacturer Narrative

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.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN ; UK
• MDR Report Key: 8890635
• MDR Text Key: 154288498
• Report Number: 1818910-2019-101033
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR