MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL SROM; METAL FEMORAL HEAD

Catalog Number UNK HIP HEAD METAL SRO

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

Patient Problem Muscular Rigidity (1968)

Event Date 02/14/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision completed due to poly wear approximately 26 years following original surgery.The cup and stem were will fixed.New head and liner were implanted without incident.No surgical delay.Doi: 1996, dor: (b)(6) 2022, affected side: left hip.

• Brand Name: UNK HIP FEMORAL HEAD METAL SROM
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13892117
• MDR Text Key: 287843136
• Report Number: 1818910-2022-05387
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2022

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 SRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 03/24/2022
• 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
• Treatment: UNK HIP ACETABULAR LINER POLY DURALOC
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male