MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM LEFT SZ5; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0084
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Necrosis (1971); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/04/2021
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
Operative notes (b)(6) 2021 indicate the patient received a left total knee surgical irrigation and debridement with wound closure due to wound dehiscence and continued infection.Upon entering the wound, necrotic tissue was excised, and a thorough irrigation was done.No implants were revised.The surgery was completed without indication of complication by the surgeon.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not 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).Where the lot code was provided, 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: 11223471
• Report Number: 1818910-2021-01757
• Device Sequence Number: 11701350
• Product Code: JWH
• UDI-Device Identifier: 10603295232513
• UDI-Public: 10603295232513
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 96-0084
• Device Catalogue Number: 960084
• Device Lot Number: J3679G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/26/2021
• 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: DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; MBT CEM KEEL TIB TRAY SZ5; PFC SIGMA FEM POST AUG SZ5 4MM; PFC*SIGMA TC3 FEM LEFT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA FEM ADAPTER 5 DEGREE; TAPER CEM STEM 13X90; UNKNOWN KNEE TIBIAL INSERT; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; MBT CEM KEEL TIB TRAY SZ5; PFC SIGMA FEM POST AUG SZ5 4MM; PFC*SIGMA TC3 FEM LEFT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA FEM ADAPTER 5 DEGREE; TAPER CEM STEM 13X90; UNKNOWN KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 122