MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD GVF INS 4 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number 1581-14-008

Device Problems Difficult to Insert (1316); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that one of the two anterior 'phalanges' had bent and therefore it was not possible to engage the tibial tray.There was a surgical delay of a few minutes.No patient harm.

• Brand Name: SIGMA CRVD GVF INS 4 8MM
• Type of Device: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12828327
• MDR Text Key: 280901481
• Report Number: 1818910-2021-25334
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295063445
• UDI-Public: 10603295063445
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

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
• Device Operator: Health Professional
• Device Model Number: 1581-14-008
• Device Catalogue Number: 158114008
• Device Lot Number: D21051477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1