MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ4; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0089
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Adhesion(s) (1695); Edema (1820); Pain (1994); No Code Available (3191)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Patient received a right knee bone decompression to treat pain and walking difficulty secondary to heterotopic ossification.Intraoperatively, the surgeon removed anterior suprapatellar bone spurs and adhesions and performed a synovectomy.All components were well-fixed and retained.The patient received an anterior adductor canal nerve block catheter for postoperative pain relief.The procedure was completed without complications.Pathology of the excised tissue was benign, and no infection was identified.No components were revised.Doi: (b)(6) 2016 (patella).Doi: (b)(6) 2018 (insert, tibial and femoral components).Doe: (b)(6) 2018 (wound debridement).Doe: (b)(6) 2019 (decompression).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.H10 additional narrative: added: h6 (patient).

• 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: 10247508
• Report Number: 1818910-2020-15324
• Device Sequence Number: 3194616
• Product Code: JWH
• UDI-Device Identifier: 10603295232568
• UDI-Public: 10603295232568
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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: 96-0089
• Device Catalogue Number: 960089
• Device Lot Number: HD3248
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/17/2020
• 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: ATTUNE MEDIAL ANAT PAT 41MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 37MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC*SIGMA TC3 FEM RT SZ4; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SYNTHES SCREW BONE (204830); TC3 RP TIBIAL INSERT S4,12.5; UNIVERSAL STEM 115X16MM FLUTED; UNIVERSAL STEM 75X18MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 118