MAUDE Adverse Event Report: DEPUY IRELAND 9616671 EA DELTA CER INSERT 36IDX54OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121881754

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the ceramic insert broke and when trying to remove it came out the cup and the apex.

Manufacturer Narrative

It was reported that the ceramic insert broke and when trying to remove it came out the cup and the apex.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EA DELTA CER INSERT 36IDX54OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6957477
• MDR Text Key: 89623665
• Report Number: 1818910-2017-26658
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121881754
• Device Lot Number: 8518762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 01/03/2018
• Supplement Dates FDA Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR