MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA DIS AUG 8MM,SZ5,LEFT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Model Number	96-0902
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	08/09/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
This pc was created to capture the event happened on (b)(6) 2013.On (b)(6) 2013, the patient had a left knee arthroscopic synovectomy to address left knee arthrofibrosis after total knee.The indications for surgery noted that the patient had a previous total knee, and then later on required a revision to a tc-iii style implant by depuy.The patient developed catching of his knee, swelling, and recurrent hemarthrosis.During this current procedure the surgeon observed peripatellar arthrofibrosis.(page 106 of 274) no components were revised.No other info was provided.Doi: (b)(6) 2011.Doe: (b)(6) 2013.Left knee.
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.
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 ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12961789
• Report Number: 1818910-2021-27538
• Device Sequence Number: 20186011
• Product Code: JWH
• UDI-Device Identifier: 10603295234487
• UDI-Public: 10603295234487
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 07/09/2021

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 Expiration Date: 02/20/2020
• Device Model Number: 96-0902
• Device Catalogue Number: 960902
• Device Lot Number: EE4RE4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2010
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT REVISION CEM TIB TRAY SZ 4.; MBT TRAY SLEEVE POR M/L 37MM.; PFC SIGMA FEM POST AUG SZ5 8MM.; PFC SIGMA FEM POST AUG SZ5 8MM.; PFC*SIGMA DIS AUG 4MM,SZ5,LEFT.; PFC*SIGMA DIS AUG 4MM,SZ5,LEFT.; PFC*SIGMA DIS AUG 8MM,SZ5,LEFT.; PFC*SIGMA TC3 FEM LEFT SZ5.; PFC*SIGMA/OV/DOME PAT 3PEG,41.; SIG FEM ADAP +2/-2 OFFSET BOLT.; SIGMA FEM ADAPTER 5 DEGREE.; TC3 RP TIBIAL INSERT S5,17.5.; UNIVERSAL FEM SLV FUL POR 40MM.; UNIVERSAL STEM 75X16MM FLUTED.; UNIVERSAL STEM 75X18MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Unknown