MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB XLK INS 3 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-23-108
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/08/2020
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
It was reported that the poly liner would not seat in tibial tray.Looks like the anterior locking tabs bent.May have been too aggressive with mallet.Opened another insert and it worked fine.Surgery delayed by 45 seconds.Liner is intact and being returned to corporate.No other information available.Doe: (b)(6) 2020.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device could not confirm the reported event.No evidence was found indicating product error was a contributing factor and the need for corrective action was not indicated.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: 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: SIGMA STAB XLK INS 3 8MM
• 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: 10719595
• Report Number: 1818910-2020-23096
• Device Sequence Number: 11047690
• Product Code: JWH
• UDI-Device Identifier: 10603295064329
• UDI-Public: 10603295064329
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/09/2020

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 Model Number: 1581-23-108
• Device Catalogue Number: 158123108
• Device Lot Number: 9550355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/24/2020; 11/10/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 10/30/2020; 11/11/2020
• 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: UNK KNEE TIBIAL TRAY SIGMA ; UNK KNEE TIBIAL TRAY SIGMA