MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURON 10D 50OD X 28ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number 124150025

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).E3: the initial reporter information has been removed for confidentiality/privacy.The initial reporter is a patient.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Patient initiated complaint: during the conversation the patient informed employee that he has been experiencing some pain again to his hip and consulted the doctor recently and has been recommended- a revision surgery due to some wear on poly liner.Since his first hip surgery in (b)(6) 2009 , the doctor is unsure if he can avail the same liner.Patient also mentioned, his implant is from j&j, he brought it to employee attention to check if the product is still available in the market.

Manufacturer Narrative

Product complaint (b)(4) investigation summary no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product part#124150025/ lot#2903824 combination.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product part#124150025/ lot#2903824 combination.Added.

• Brand Name: ENDURON 10D 50OD X 28ID
• Type of Device: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18903850
• MDR Text Key: 337660852
• Report Number: 1818910-2024-05704
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 124150025
• Device Lot Number: 2903824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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: ARTICUL/EZE BALL 28 +5 BR; DURALOC 100 SERIES 50MM OD; SUMMIT POR TAPER SZ4 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male