MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ2 10; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Without the physical complaint sample associated with this report, it was not possible to conclusively determine if the device failed to meet specification.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.(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
Clinical adverse event received for instability.Event is serious and is considered severe.Event is definitely related to device and there is a remote possibility that it is related to procedure.Date of implantation: (b)(6) 2015.Date of event (onset): (b)(6) 2019; (left 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 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.Corrected h6 patient code: no code available (3191) is being used to capture device revision and replacement and joint instability.If information is obtained that was not available for the initial report, a follow-up report 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.

• Brand Name: SIG RP AOX CRV INS SZ2 10
• 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: 9996520
• Report Number: 1818910-2020-11292
• Device Sequence Number: 11736398
• Product Code: NJL
• UDI-Device Identifier: 10603295076087
• UDI-Public: 10603295076087
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2019

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 Model Number: 1961-92-011
• Device Catalogue Number: 196192011
• Device Lot Number: 3433544
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 09/21/2020; 05/11/2021
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 09/22/2020; 05/13/2021
• 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 2 20G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ2; PFC*SIGMA C/R NPOR FEM LT SZ 2; PFC*SIGMA/OV/DOME PAT 3PEG,35; DEPUY CMW 2 20G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ2; PFC*SIGMA C/R NPOR FEM LT SZ 2; PFC*SIGMA/OV/DOME PAT 3PEG,35
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 61