MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 3 15.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	962133
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Myocardial Infarction (1969); Pleural Effusion (2010); Pulmonary Edema (2020); Heart Failure (2206)
Date of Event	06/06/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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
Update 03 jan 2019: on (b)(6) 2014, 3 days after left tka revision, patient developed pulmonary edema and congestive heart failure with possible mi.He underwent a cabg x 5 for 3 vessel cardiac disease on (b)(6) 2014.Patient developed bilateral pleural effusions and infection after cabg requiring sternal wound vac and iv antibiotic on (b)(6) 2014.Doi: (b)(6) 2014.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMARP STB TB IN 3 15.0
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8539776
• Report Number: 1818910-2019-91329
• Device Sequence Number: 399984
• Product Code: NJL
• UDI-Device Identifier: 10603295241263
• UDI-Public: 10603295241263
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2019

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: 07/31/2018
• Device Catalogue Number: 962133
• Device Lot Number: 7296309
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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: 58 YR