MAUDE Adverse Event Report: JJM (SUZHOU) LTD. 3006356043 PFC*SIGMA/RD/DOME PAT 3PEG,35; SIGMA KNEE PRIMARY : KNEE PATELLA

Catalog Number	960111
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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.Device history lot: product code 960111, lot number d11061259.Device history batch: null.Device history review: dhr review.Product code 960111, work order /lot no.D11061259 was manufactured on 29-jun-2011.One hundred and twenty parts were manufactured per specification and all raw materials met specification.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 reported that the patient fell and landed on her left knee.X-ray's showed a disruption in the patella/bone interface.Upon open exploration it was determined that the patella component was fractured.Loosening of the patella at the bone/cement interface.The surgeon also elected to exchange the tibial insert to a large-thickness.Doi: (b)(6) 2012; dor: (b)(6) 2018; left knee.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou industrial park suzhou 21512 -6; CH 21512-6
• MDR Report Key: 7813029
• Report Number: 1818910-2018-67625
• Device Sequence Number: 1345829
• Product Code: JWH
• UDI-Device Identifier: 10603295232667
• UDI-Public: 10603295232667
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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: 960111
• Device Lot Number: D11061259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 08/24/2018
• 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: 78 YR