MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD GVF INS 5 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-15-010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/12/2020
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
High volume surgeon went to impact the definitive liner and the anterior locking mechanism broke.Fortunately, there was a loan one available.This happened at the end of the case.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : examination of the returned device could not confirm the reported event.No evidence was found indicating product error was a contributing factor and the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d10 corrected: h3 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SIGMA CRVD GVF INS 5 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10208400
• Report Number: 1818910-2020-14618
• Device Sequence Number: 3270491
• Product Code: JWH
• UDI-Device Identifier: 10603295063582
• UDI-Public: 10603295063582
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2020

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 Model Number: 1581-15-010
• Device Catalogue Number: 158115010
• Device Lot Number: D20011271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 07/06/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/02/2020; 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR