MAUDE Adverse Event Report: JJM (SUZHOU) LTD. 3006356043 SIGMA STAB GVF INS 3 15MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158123015
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	01/03/2018
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
Revision due to loosening.
Additional Manufacturer Narrative
Product complaint #: (b)(4).The date on the initial medwatch should have been 12/11/2018.
Additional Manufacturer Narrative
(b)(4).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.

• Brand Name: SIGMA STAB GVF INS 3 15MM
• 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: 8159723
• Report Number: 1818910-2018-78020
• Device Sequence Number: 14002875
• Product Code: JWH
• UDI-Device Identifier: 10603295064275
• UDI-Public: 10603295064275
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2018

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 Expiration Date: 01/29/2017
• Device Catalogue Number: 158123015
• Device Lot Number: D12010664
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 12/21/2018; 12/11/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 12/26/2018; 01/10/2019
• 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: 59 YR