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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 04/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

Event Description

After a review of the medical records, the patient was revised to address failed right total hip arthroplasty due to adverse local tissue reaction associated with ceramic-on-metal articulation.Patient alleges chronic groin pain and elevated metal ions.Radiographs demonstrated a probable metal-on-metal cementless right total hip replacement with evidence of a small lytic lesion superior to the acetabulum.Operative notes stated that a robust posterior capsular scar was elevated posteriorly.Upon entering the affected joint space, there was a rush of gray-turbid joint fluid.Synovial tissue and the joint space were stained a faint gray color.There was an area of metal deposit on the femoral head that was clearly not associated with our retractors or metal contact with the head.There was no evidence of corrosion at the femoral taper.There was a lytic lesion anteriorly and superiorly.Doi: 2005; dor: (b)(6) 2019 (right hip).

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9934215
• MDR Text Key: 187731908
• Report Number: 1818910-2020-10368
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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: 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR