MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DELTA CER HEAD 11/13 32MM +6; HIP FEMORAL HEAD

Catalog Number	136532230
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Event report stated that patient reported symptoms of extreme pain and ambulation difficulties.Patient has an allergy to nickel and vanadium.
Additional Manufacturer Narrative
No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.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 11/13 32MM +6
• Common Device Name: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 6732393
• Report Number: 1818910-2017-21562
• Device Sequence Number: 18995879
• Product Code: LZO
• UDI-Device Identifier: 10603295033424
• UDI-Public: 10603295033424
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 136532230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention