MAUDE Adverse Event Report: ENDURON 10D 54OD X 26ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number 124054025

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/11/2021

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.

Event Description

Pt had significant hip infection, femoral stem was well fixed and stable so left insitu, but surgeon removed duraloc cup and poly.Doi: unknown, dor: (b)(6) 2021, left hip.

Manufacturer Narrative

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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 : a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.

• Brand Name: ENDURON 10D 54OD X 26ID
• Type of Device: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• MDR Report Key: 12540241
• MDR Text Key: 273570371
• Report Number: 1818910-2021-21246
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

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: 124054025
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DURALOC OPTION CUP 54MM; ENDURON 10D 54OD X 26ID; UNK HIP LOCKING RING; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; DURALOC OPTION CUP 54MM; ENDURON 10D 54OD X 26ID; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR