MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIG RP AOX STB INS SZ3 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	196192133
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Der states that per the surgeon the patient had knee pain.Patient had an unsurfaced patella from initial surgery.Surgery resurfaced the patella.Also, patient was a little unstable with current 15 mm insert, and the surgeon went to a 17.5 mm insert.No instrumentation broke during case.Unknown on original case so don¿t have the product numbers for femur and tibia that stayed in.Doi: unknown; dor: (b)(6) 2018; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Device history lot: null.Device history batch: null.Device history review: null.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 STB INS SZ3 15
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7316001
• Report Number: 1818910-2018-54572
• Device Sequence Number: 1372293
• Product Code: NJL
• UDI-Device Identifier: 10603295076537
• UDI-Public: 10603295076537
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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: 196192133
• Device Lot Number: 7871563
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 03/06/2018
• 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: 81 YR
• Patient Weight: 89