MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIG RP AOX CRV INS SZ3 15; KNEE TIBIAL BEARING/INSERT

Model Number	1961-92-033
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Synovitis (2094)
Date of Event	05/25/2017
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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
Clinical der states that an ae was received for infection.Event meets the definition of serious and is considered moderate.Event is definitely not related to device and possibly related to procedure.Treatment includes irrigation and débridement.Event is considered resolved.Update: jun 05, 2017: the patient was revised to address infection on (b)(6) 2017.Depuy insert was revised.This complaint was updated on jun 14, 2017.
Additional Manufacturer Narrative
Additional narrative: the device associated with this report was not received for examination.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.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIG RP AOX CRV INS SZ3 15
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 6662611
• Report Number: 1818910-2017-20026
• Device Sequence Number: 13845063
• Product Code: NJL
• UDI-Device Identifier: 10603295076186
• UDI-Public: (01)10603295076186
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/20/2017

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 Model Number: 1961-92-033
• Device Catalogue Number: 196192033
• Device Lot Number: 8201095
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 07/20/2017; 09/29/2017; 09/29/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 08/08/2017; 09/29/2017; 10/02/2017
• 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: 65 YR
• Patient Weight: 84