MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD

Catalog Number UNK HIP HEAD METAL

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

Patient Problems Discomfort (2330); Joint Laxity (4526)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: 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

It was reported that the surgeon said the patient had their hip done back in 2007 by the surgeon.He was not sure of the exact date or the location of her surgery.The patient was suffering from hip discomfort and instability.When looking at the cup positioning, the cup appeared to be placed vertically.The surgeon believed the patient would benefit from a cup revision.He removed the depuy acetabular components, and that¿s when he realized it was a metal on metal prosthesis.He believed this could be contributing to her hip discomfort as well.He opted to implant a zimmer biomet acetabular component to use their dual mobility construct.This required one of our 28mm ts ceramic heads to pair with the summit stem that was left implanted.After a trial reduction was performed, a 28mm +5 head was deemed the appropriate length for the patient.The real head was opened and implanted.The hip was found to be stable and the closing process began.Doi: 2007 - dor: (b)(6) 2021 (unknown side).

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11575067
• MDR Text Key: 242704748
• Report Number: 1818910-2021-06244
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2021

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
• Device Catalogue Number: UNK HIP HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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: 50 YR