MAUDE Adverse Event Report: JJM (SUZHOU) LTD. 3006356043 SIGMA STAB GVF INS 3 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158123012
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
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
Deflection product during implementation.To procedure completed physician used another one product the same type.No consequences for the patient reported.
Event or Problem Description
Update additional information received: there was a less than 30 minute surgery delay.
Additional Manufacturer Narrative
Investigation summary: no device associated with this report was received for examination.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• Brand Name: SIGMA STAB GVF INS 3 12.5MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• MDR Report Key: 7805092
• Report Number: 1818910-2018-67390
• Device Sequence Number: 1535365
• Product Code: JWH
• UDI-Device Identifier: 10603295064268
• UDI-Public: 10603295064268
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 158123012
• Device Lot Number: D17030431
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/06/2018; 09/18/2018; 10/12/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/12/2018; 09/25/2018; 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1