MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFCSIG STAB ALPOLYTIB 12.5MMS5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	962662
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that an expired 5 x 12.5mm all poly tibial component was implanted and was not caught until after the surgery and patient was in recovery.Doe: (b)(6) 2018, on left knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination, however review of the provided information confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFCSIG STAB ALPOLYTIB 12.5MMS5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8137599
• Report Number: 1818910-2018-77382
• Device Sequence Number: 16515832
• Product Code: JWH
• UDI-Device Identifier: 10603295243731
• UDI-Public: 10603295243731
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K950010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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 Catalogue Number: 962662
• Device Lot Number: D13050939
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 117