MAUDE Adverse Event Report: DEPUY (IRELAND) 9616671 DUR OPT CER INS 32/52; HIP ACETABULAR INSERT/LINER

Catalog Number 159964052

Device Problem Fracture (1260)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932)

Event Date 11/09/2016

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

Clinical report states patient was revised to address femoral stem loosening.Update (b)(6) 2017: medical records received.After review of the medical records for mdr reportability, the revision operative note indicated clear yellow effusion, metallosis/chronic inflammation, loose stem, and fractured liner-all fragments removed.Its unknown if the liner was fractured before revision or while trying to remove it at revision.The acetabular cup was also revised due to a central bone defect about the size of a dime and posterosuperior defect.The liner and head are now being reported.This complaint was updated on: (b)(6) 2017.

Manufacturer Narrative

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.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.

• Brand Name: DUR OPT CER INS 32/52
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY (IRELAND) 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6276089
• MDR Text Key: 65705710
• Report Number: 1818910-2017-11405
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P044023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

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: 159964052
• Device Lot Number: 2899921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 01/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2009
• 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: 36 YR
• Patient Weight: 118