MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM LEFT SZ3; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0082
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
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
Subject id: (b)(6).Study: dots.Clinical adverse event received for patellar clunk, moderate in nature: patella clunk syndrome.Event is not serious and is considered moderate there is a remote possibility that the event is possibly related device and is possibly related to procedure.Date of implantation: (b)(6) 2019.Date of revision: (b)(6) 2021 (femur and insert).Date of event (onset): (b)(6) 2021.(left knee).Treatment: none.
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
On (b)(6) 2021, the patient presented for a left knee evaluation due to patella clunk.The physician indicated the left knee developed a lot of scar tissue and some laxity.The physician indicated if the patient's symptoms worsen he would be a candidate for an arthroscopic debridement.There is no evidence of revision, invasive intervention, or treatment.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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: 12010444
• Report Number: 1818910-2021-12821
• Device Sequence Number: 3304041
• Product Code: JWH
• UDI-Device Identifier: 10603295232490
• UDI-Public: 10603295232490
• 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: 2021
• 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,Followup
• Report Date (Section B): 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-0082
• Device Catalogue Number: 960082
• Device Lot Number: J42N28
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/15/2021; 07/29/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/12/2021; 07/29/2021
• 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: DEPUY CMW 1 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; MBT CEM KEEL TIB TRAY SZ4; PFC SIGMA FEM POST AUG SZ3 4MM; PFC SIGMA FEM POST AUG SZ3 8MM; PFC*SIGMA DIS AUG 4MM,SZ3,LEFT; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG FEM ADAP +2/-2 OFFSET BOLT; SIG RP AOX STB INS SZ3 15; SIGMA FEM ADAPTER 5 DEGREE; TAPER CEM STEM 13X90
• Patient Age: 72 YR
• Patient Weight: 82