MAUDE Adverse Event Report: DEPUY IRELAND 9616671 PFC SIGMARP CV TB/IN S4 15.0; KNEE TIBIAL BEARING/INSERT

Catalog Number	962043
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/01/2017
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
It was indicated that polyethylene fracture of 962043, 4x15 rp cr insert secondary to instability replaced with a 4x17.5 rp cr tibial insert.Update 8-1-2017: medical records have been reviewed.Operative note (b)(6) 2009 indicates the patient received a right total knee replacement due to degenerative joint disease of the right knee.The procedure was completed without any complication noted by the surgeon.
Additional Manufacturer Narrative
Additional narrative: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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: PFC SIGMARP CV TB/IN S4 15.0
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 6830980
• Report Number: 1818910-2017-23732
• Device Sequence Number: 16361938
• Product Code: NJL
• UDI-Device Identifier: 10603295240839
• UDI-Public: 10603295240839
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 08/01/2017

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 Expiration Date: 02/25/2014
• Device Catalogue Number: 962043
• Device Lot Number: 2856609
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 09/13/2017
• 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
• Patient Age: 67 YR
• Patient Weight: 103