MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*CVD TB INS SZ4, 8.00MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	98-4152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/21/2020
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 to address instability, tibial subsidence and loosening of tibial component at the bone to cement interface.Femur was stable.Unknown cement was used.Original surgery was done 26 years ago.No surgical delay.Doi: 26 years ago, dor: (b)(4) 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.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10621685
• Report Number: 1818910-2020-21498
• Device Sequence Number: 1178859
• Product Code: JWH
• UDI-Device Identifier: 10603295252429
• UDI-Public: 10603295252429
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/21/2020

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: 98-4152
• Device Catalogue Number: 984152
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/07/2020
• 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: UNKNOWN KNEE FEMORAL; UNKNOWN KNEE PATELLA; UNKNOWN KNEE TIBIAL TRAY; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE PATELLA; UNKNOWN KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR