MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA FEM POST AUG SZ3 8MM; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Model Number	96-0868
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Medical records from (b)(6) 2020 note that the patient went the er due to worsening left knee pain and got an injection of toradol.Doi: (b)(6) 2016.Dor: (b)(6) 2017.(captured in (b)(4)).Doe: (b)(6) 2020.Left knee.
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.

• Brand Name: PFC SIGMA FEM POST AUG SZ3 8MM
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10582993
• Report Number: 1818910-2020-20883
• Device Sequence Number: 16286756
• Product Code: JWH
• UDI-Device Identifier: 10603295234319
• UDI-Public: 10603295234319
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 06/30/2021
• Device Model Number: 96-0868
• Device Catalogue Number: 960868
• Device Lot Number: 112211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOMET COBALT HV WITH GENTAMICIN BONE CEMENT; BIOMET COBALT HV WITH GENTAMICIN BONE CEMENT; MBT REVISION CEM TIB TRAY SZ 5; PFC SIGMA FEM POST AUG SZ3 4MM; SIG FEM ADAP +2/-2 OFFSET BOLT; SIG RP AOX STB INS SZ6 12.5; SIGMA FEM ADAPTER 5 DEGREE; SIGMA PS CEM FEM SZ6 L; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X18MM FLUTED; UNKNOWN KNEE PATELLA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR