MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DELTA CER HEAD 12/14 36MM +1.5; HIP FEMORAL HEAD

Catalog Number 136536310

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 05/08/2017

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

The patient was revised due to squeak and pain.

Manufacturer Narrative

Conclusion and justification status: the initial review of the information made available to the investigation found the product was to specification at the time of manufacturing.This information has been sent for further investigation to the ceramic supplier.The supplier will carry out further in-depth analysis to assist in the determination of the root cause.The investigation shall be closed with an interim report and be reopened when the suppliers report is completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The patient was revised due to squeak and pain.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: DELTA CER HEAD 12/14 36MM +1.5
• Type of Device: HIP FEMORAL HEAD
• 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: 6616090
• MDR Text Key: 76816208
• Report Number: 1818910-2017-19042
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2017

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: 136536310
• Device Lot Number: 4482591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 06/30/2017; 11/09/2017
• Supplement Dates FDA Received: 07/05/2017; 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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