MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA DI AUG16MMCO,SZ4RGHT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Model Number	96-0892
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2021
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 to address fracture below the tibia implant and loosening of the tibial component at the unknown interface.Unknown cement was used.It was reported that the tc3 and mbt tray components were explanted, the fracture was reduced and plated by another surgeon.An attune revision construct was implanted in place.No surgical delay.Doi: (b)(6) 2021, dor: (b)(6) 2021, 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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a dhr review was conducted by the manufacturing site.The dhr review revealed, one unrelated nonconformance (nr-0036132) associated with the provided product code and lot combination.

• 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: 12127548
• Report Number: 1818910-2021-14486
• Device Sequence Number: 17001192
• Product Code: JWH
• UDI-Device Identifier: 10603295234456
• UDI-Public: 10603295234456
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 06/17/2021

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: 96-0892
• Device Catalogue Number: 960892
• Device Lot Number: C12235
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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 REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 29MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC*SIGMA DI AUG12MMCO,SZ4RGHT; PFC*SIGMA DI AUG16MMCO,SZ4RGHT; PFC*SIGMA TC3 FEM RT SZ4; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,17.5; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 115X10MM FLUTED; UNIVERSAL STEM 75X12MM FLUTED; MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 29MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC*SIGMA DI AUG12MMCO,SZ4RGHT; PFC*SIGMA DI AUG16MMCO,SZ4RGHT; PFC*SIGMA TC3 FEM RT SZ4; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,17.5; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 115X10MM FLUTED; UNIVERSAL STEM 75X12MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR