MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM LEFT S2.5; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0086
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Synovitis (2094)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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
Revision operative notes (b)(6) 2019 indicate the patient received a left total knee revision due to pain, limited range of motion and loosening and misposition of the femoral component.Upon entering the joint, thickened synovium was encountered and a synovectomy was performed.The femoral component was noted to be loose at the bone to cement interface.It was also indicated that the femoral component had been previously placed in a state of flexion misposition, this was also correct with implantation of a new femoral component in proper position.Femoral component and insert were revised.Depuy products were implanted along with competitor cement.The surgery was completed without indication of complication by the surgeon.Doi: (b)(6) 2016 (patella).Doi: (b)(6) 2018 (insert, tibial and femoral components).Dor: (b)(6) 2019.Left 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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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: 11166036
• Report Number: 1818910-2021-01032
• Device Sequence Number: 3559281
• Product Code: JWH
• UDI-Device Identifier: 10603295232537
• UDI-Public: 10603295232537
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: 96-0086
• Device Catalogue Number: 960086
• Device Lot Number: HT4976
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/19/2021
• 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: ATTUNE MEDIAL DOME PAT 32MM; MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 29MM; PFC SIG FEM POST AUG SZ2.5 8MM; PFC SIG FEM POST AUG SZ2.5 8MM; PFC SIGMARP STB TB IN 2.5 10.0; PFC*SIGMA TC3 FEM LEFT S2.5; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT; UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL STEM 75X12MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR