MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 3 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number 1581-23-010

Device Problem Expiration Date Error (2528)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2023

Event Type  malfunction  

Event Description

It was reported that product was implanted with an expiration date the may 31, 2022.

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.

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.

Event Description

Additional information received indicated that it was unknown if there was patient consequence.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation, nor photographs were provided.However based on the event description, device and other information provided, the reported allegation can be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation was performed for the finished device product 158123010 lot number d17061267 and no non-conformances / manufacturing irregularities were identified.

• Brand Name: SIGMA STAB GVF INS 3 10MM
• 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): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu IN 21512 6; CH 215126
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16974459
• MDR Text Key: 315673583
• Report Number: 1818910-2023-10583
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295064251
• UDI-Public: 10603295064251
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 05/22/2023

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: 1581-23-010
• Device Catalogue Number: 158123010
• Device Lot Number: D17061267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 05/24/2023; 06/07/2023
• Supplement Dates FDA Received: 05/29/2023; 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1