MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG PS CEM FEM W/LUGS RT SZ4N; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-79-500
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2020
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's knee was revised to address loosening of the tibial component at the cement to implant interface.Cement manufacturer unknown.Surgeon noted construct was off label: 4 rp ps femur with 2.5 mbt tibia was explanted.Implant debonded from cement mantel.No surgical delay.Doi: (b)(6) 2012, 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.H10 additional narrative: added: d7a, d9.

• Brand Name: SIG PS CEM FEM W/LUGS RT SZ4N
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11049420
• Report Number: 1818910-2020-27378
• Device Sequence Number: 11076782
• Product Code: JWH
• UDI-Device Identifier: 10603295075530
• UDI-Public: 10603295075530
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 12/07/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1960-79-500
• Device Catalogue Number: 196079500
• Device Lot Number: E68F34
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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: MBT CEM KEEL TIB TRAY SZ2.5; PFC SIGMARP STB TB IN 4 10.0; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 83