MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG MOD TIB TRAY CEM COCR 2.5; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number 1581-25-000

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2022

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 when the implant packaging of size 2.5 cocr tray was opened, a titanium tray of size 2 was found.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.Photographic evidence was provided and reviewed.Photo evidence is insufficient to confirm complaint.Reported condition is not confirmed.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 manufacturing record evaluation was performed for the finished device (product code 158125000/lot 9797889) product and lot numbers, and no non-conformances were identified.

• Brand Name: SIG MOD TIB TRAY CEM COCR 2.5
• Type of Device: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14207385
• MDR Text Key: 290068432
• Report Number: 1818910-2022-07539
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295064565
• UDI-Public: 10603295064565
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K032151
• 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: 04/26/2022

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: 1581-25-000
• Device Catalogue Number: 158125000
• Device Lot Number: 9797889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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