MAUDE Adverse Event Report: DEPUY IRELAND 9616671 PFC*SIGMA/RD/DOME PAT 3PEG,32; KNEE PATELLAR COMPONENT

Catalog Number	960110
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/27/2017
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
Patient was revised to address infection and loosening of the unknown component at bone to cement interface, cement manufacturer is unknown.The implants were loose because of infection.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: KNEE PATELLAR COMPONENT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 6977738
• Report Number: 1818910-2017-27451
• Device Sequence Number: 13826836
• Product Code: JWH
• UDI-Device Identifier: 10603295232650
• UDI-Public: 10603295232650
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2017

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: 960110
• Device Lot Number: 8138055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 11/01/2017; 11/01/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 11/03/2017; 11/06/2017
• 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