MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX STB INS SZ3 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-132
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Pain (1994); No Code Available (3191)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).
Event or Problem Description
After review of medical record dated (b)(6) 2020, it was reported that patient suffered from adhesion, pain, allergic reaction.Doi: (b)(6) 2018, dor: (b)(6) 2019, right knee.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate. .
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : update 04-feb-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.Visual examination of the provided x-ray images confirmed the reported event.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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.

• Brand Name: SIG RP AOX STB INS SZ3 12.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9908051
• Report Number: 1818910-2020-09814
• Device Sequence Number: 13625746
• Product Code: NJL
• UDI-Device Identifier: 10603295076520
• UDI-Public: 10603295076520
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2019

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 Expiration Date: 02/28/2021
• Device Model Number: 1961-92-132
• Device Catalogue Number: 196192132
• Device Lot Number: 8263556
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 05/05/2020; 02/22/2021
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 05/11/2020; 02/23/2021
• 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: MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 37MM; PFC* FLUT TIB ROD TRL 75 X 14; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG RP AOX STB INS SZ3 12.5; SIGMA PS CEM FEM SZ3 R; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR