MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ3 7MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number	102454307
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Intraoperatively it had not been possible to fix the inlay.It did not lock with the tibial part.Another inlay was available and was inserted and fixed without any issues.Surgery prolongation 5 minutes.No adverse consequences for patient or user.
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.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary examination of the returned device 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.Device history lot product code (b)(4), lot number h16233.Device history review no anomalies or deviations were found for the operations performed at the warsaw site.See attached dhr for details.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.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summaryexamination of the returned device 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.Device history review no anomalies or deviations were found for the operations performed at the warsaw site.See attached dhr for details.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: SIGMA HP UNI INS SZ3 7MM RM/LL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7233511
• Report Number: 1818910-2018-52478
• Device Sequence Number: 16600789
• Product Code: HRY
• UDI-Device Identifier: 10603295002833
• UDI-Public: 10603295002833
• Combination Product (Y/N): N
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/15/2018

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: 102454307
• Device Lot Number: H16233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 03/15/2018; 05/04/2018; 05/04/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 03/28/2018; 05/09/2018; 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1