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

Model Number 1581-23-110

Device Problem Expiration Date Error (2528)

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

Event Date 04/08/2021

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 by physician that there was a surgery where there was an implant used that was expired.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.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.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA STAB XLK 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
• MDR Report Key: 11760693
• MDR Text Key: 248502144
• Report Number: 1818910-2021-09404
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295064336
• UDI-Public: 10603295064336
• Combination Product (y/n): N
• PMA/PMN Number: K040166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 1581-23-110
• Device Catalogue Number: 158123110
• Device Lot Number: 8254250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIG MOD TIB TRAY CEM COCR 3; SIGMA PS CEM FEM SZ3 R; SIGMA STAB XLK INS 3 10MM; SIG MOD TIB TRAY CEM COCR 3; SIGMA PS CEM FEM SZ3 R; SIGMA STAB XLK INS 3 10MM