MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PFC SIGMA MOD TIB TRAY CEM SZ4; KNEE IMPLANT

Catalog Number	866024
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2017
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
The patient was revised to address loose tibia at an unknown interface, cement manufacturer is unknown.It was also stated that an mbt revision tray 4x15 and a 15mmx5 cudrp poly was reimplanted for stability.Doi: 1997; dor: (b)(6) 2017; right knee.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Investigation summary = > no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: PFC SIGMA MOD TIB TRAY CEM SZ4
• Common Device Name: KNEE IMPLANT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7121055
• Report Number: 1818910-2017-51788
• Device Sequence Number: 1358100
• Product Code: JWH
• UDI-Device Identifier: 10603295216797
• UDI-Public: 10603295216797
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K882234
• 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
• Report Date (Section B): 11/22/2017

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: 866024
• Device Lot Number: 866024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 04/23/2018
• 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
• Patient Age: 71 YR