MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DELTA CER HEAD 12/14 36MM +5; HIP FEMORAL HEAD

Catalog Number 136536320

Device Problem Disassembly (1168)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this 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 a fractured poly liner and disassociation from the cup due to a traumatic fall.Report also noted that the femoral head was riding within the cup creating metallosis.

Manufacturer Narrative

Patient was revised to address a fractured poly liner and disassociation from the cup due to a traumatic fall.Report also noted that the femoral head was riding within the cup creating metallosis.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: DELTA CER HEAD 12/14 36MM +5
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6208552
• MDR Text Key: 63381928
• Report Number: 1818910-2016-33953
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136536320
• Device Lot Number: 8043546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• 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: 39 YR