MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 SIGMA PLI XLK INS 4 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158104108
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2018
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
Der states during a left total knee, and insertion and impaction of an insert, one of the anterior locking mechanisms broke.The rep had another one on-site and that one went in no problem.No pieces came detached from the insert and there was nothing left in the patient to retrieve.Surgeon feels he didn't have the insert posteriorly enough and when he impacted it the locking tab was damaged.Doe: (b)(6) 2018.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Device history lot: product code 158104108, lot number 8250465.Device history review: 24 parts were manufactured per specification and all raw materials met specification.There were no ncs or deviations associated with this.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 PLI XLK INS 4 8MM
• 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: 7593279
• Report Number: 1818910-2018-61965
• Device Sequence Number: 16568708
• Product Code: JWH
• UDI-Device Identifier: 10603295062660
• UDI-Public: 10603295062660
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• 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): 05/16/2018

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: 158104108
• Device Lot Number: 8250465
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 91