MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 PFC SIGMA STAB+ INS 22.5MM SZ4; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	962745
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 stated that the size 4 22.5 stabilized plus insert would not seat into tibia.Post may have been damaged.There was a 30 minute surgical delay.Doe: (b)(6) 2018.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.Device history lot: product code: (b)(4), lot number: (b)(4).Device history review: dhr reviewed - no deviations or nonconformance were noted.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMA STAB+ INS 22.5MM SZ4
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7388261
• Report Number: 1818910-2018-56462
• Device Sequence Number: 48645
• Product Code: JWH
• UDI-Device Identifier: 10603295244264
• UDI-Public: 10603295244264
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K963117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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: 962745
• Device Lot Number: 710377
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 126