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 Code	No Code Available (3191)
Date of Event	07/08/2020
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
The patient was revised due to mcl rupture.Revised femoral component and tibial poly to a srom hinge.Doi: (b)(6) 2019.Dor: (b)(6) 2020; right 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: 10291864
• Report Number: 1818910-2020-16219
• Device Sequence Number: 860332
• Product Code: JWH
• UDI-Device Identifier: 10603295234319
• UDI-Public: 10603295234319
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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 Model Number: 96-0868
• Device Catalogue Number: 960868
• Device Lot Number: HN0154
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/25/2020
• 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: PFC SIGMA FEM POST AUG SZ3 4MM; PFC SIGMA FEM POST AUG SZ3 8MM; PFC*SIGMA DIS AUG 4MM,SZ3,RGHT; PFC*SIGMA DIS AUG 8MM,SZ3,RGHT; PFC*SIGMA TC3 FEM RT SZ3; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S3,12.5; UNIVERSAL STEM 115X16MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR