MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Pain (1994); Injury (2348); Osteolysis (2377); No Code Available (3191)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Us fda mdr determination: there were no reported product problems with the cup.It is reasonable to conclude that the reported patient harms are attributed to the stem corrosion and the pseudotumor which is associated with the articulating surface.(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

Medical records received.After review of medical records, the patient was revised to address a failed right total hip arthroplasty with pain, pseudotumor and increased levels of cobalt and chrome.X-rays show loosening on the calcar around the lesser trochanter.Intraoperatively there was approximately 50 cc yellowish milky fluid, osteolysis, spot welding on the proximal femur, bone loss, oxidation and blackening on the trunnion.The surgeon performed an extended trochanteric osteotomy and as the stem was being removed, the proximal calcar fractured.There was a concern that there might be an infection so the surgeon went in an implanted an antibiotic spacer.Doi: (b)(6) 2011.Dor: (b)(6) 2018, (right hip).

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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.The information received will be retained for potential series investigations if triggered by trend analysis 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9779935
• MDR Text Key: 181787385
• Report Number: 1818910-2020-06648
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR