MAUDE Adverse Event Report: DEPUY INTL., LTD. ¿ REG. # 8010379 ENDURON NEUT 58 OR 70ODX28ID; HIP ACETABULAR INSERT/LINER

Catalog Number 124118025

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(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

Patient was revised to address poly wear and osteolysis.

Manufacturer Narrative

Duraloc head and liner revision performed on 31/08/2016 primary op in 1999, revision required due to poly wear and osteolysis.Head and liner were extracted as per surgical technique and replaced with the following: 58 36+4 10 degree liner, 58 locking ring and head was merete (lima).This case is not being reported by the customer, but jjm employee.All available information has been provided as part of this report; no further information will be forthcoming.Update 09 sept 2016 - the cup & stem remained in situ.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.

• Brand Name: ENDURON NEUT 58 OR 70ODX28ID
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY INTL., LTD. ¿ REG. # 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL., LTD. ¿ REG. # 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5936777
• MDR Text Key: 54214639
• Report Number: 1818910-2016-26821
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 124118025
• Device Lot Number: WNP94
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• 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: 61 YR