MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ2.5; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0092
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/28/2020
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
The patient was revised due to pain.Unknown bone cement was used.No surgical delay.Doi: not indicated/unknown; 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.Device history lot: no lot information available.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11142675
• Report Number: 1818910-2021-00734
• Device Sequence Number: 14463798
• Product Code: JWH
• UDI-Device Identifier: 10603295232599
• UDI-Public: 10603295232599
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 96-0092
• Device Catalogue Number: 960092
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/15/2021
• 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 SIG FEM POST AUG SZ2.5 4MM.; PFC SIG FEM POST AUG SZ2.5 8MM.; PFC*SIGMA DIS AUG8MM,S2.5,RGHT.; PFC*SIGMA DIS AUG8MM,S2.5,RGHT.; SIGMA FEM ADAPTER 5 DEGREE.; SIGMA FEM ADAPTER NEUTRAL BOLT.; TC3 RP TIBIAL INSERT S2.5,15.0.
• Outcome Attributed to Adverse Event: Required Intervention