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

Model Number	96-0083
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/09/2021
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.(b)(4).
Event or Problem Description
Clinical adverse event received for crepitation and discomfort: patella clunk syndrome event is not serious and is considered moderate.Event is possibly related to device and is related to procedure.Date of implantation: (b)(6) 2016.Date of revision: (b)(6) 2017.Date of event (onset): (b)(6) 2021.(left knee).Treatment: none.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available x-rays and photographs were reviewed.It is not possible to confirm a depuy's product failure as well as a relation between the adverse event and the reported product.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.
Event or Problem Description
Medical records from (b)(6) 2021 state that the patient was post revision left total knee arthroplasty.The patient was noted to have had a previous left total knee arthroplasty revision, as well as a knee arthroscopy for patella clunk.The left knee was noted to start to grind again, with a lot of popping and clunking in the knee.The patient is reported to have pain.The right knee is status post arthroplasty and is noted to have no limitations, concerns or complaints with the right knee.
Additional Manufacturer Narrative
Product complaint # (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.Added: b1 (is adverse event), b2 (is required intervention), b5, d10 and h6 (clinical code).H6 clinical symptoms code: appropriate term/code not available (e2402) used to capture musculoskeletal system.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h1 and h6 (impact code).

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 1210 ward av; west chester, PA 19380 ; 6107428552
• MDR Report Key: 13111206
• Report Number: 1818910-2021-28942
• Device Sequence Number: 4589153
• Product Code: JWH
• UDI-Device Identifier: 10603295232506
• UDI-Public: 10603295232506
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2022

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: 96-0083
• Device Catalogue Number: 960083
• Device Lot Number: H86687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/06/2022; 02/03/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/21/2022; 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY CMW 1 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT REVISION CEM TIB TRAY SZ 4; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC*SIGMA DIS AUG 4MM,SZ4,LEFT; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,22.5; UNIVERSAL FEM SLV DIS POR 34MM; UNIVERSAL STEM 75X12MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 108 KG