MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 4 15.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2143
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Case missing labels for patient.No problems otherwise.No delays.
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.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.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: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PFC SIGMARP STB TB IN 4 15.0
• 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: 10829548
• Report Number: 1818910-2020-24429
• Device Sequence Number: 4119736
• Product Code: NJL
• UDI-Device Identifier: 10603295241331
• UDI-Public: 10603295241331
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/27/2020

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 Expiration Date: 07/31/2022
• Device Model Number: 96-2143
• Device Catalogue Number: 962143
• Device Lot Number: 8594677
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 10/27/2020; 01/11/2021; 01/11/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 11/16/2020; 01/13/2021; 01/14/2021
• 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: ARTICULEZE M 28MM 5; ARTICULEZE M 28MM 5; ARTICULEZE M 28MM 5