MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA XLK CVD PLUS INS 5 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	97-0471
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
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
The patient was revised due to fall while doing squats.The polyethylene insert was revised from a 5x10mm insert to a 5x12.5mm insert.The reason for the poly exchange was the patient was a little loose in flexion and extension.Wanted to go up a size due to the ligaments being stretched from the fall.Doi: (b)(6) 2018; dor: (b)(6) 2020; left knee.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.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 XLK CVD PLUS 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: 9641834
• Report Number: 1818910-2020-03339
• Device Sequence Number: 11388026
• Product Code: JWH
• UDI-Device Identifier: 10603295250678
• UDI-Public: 10603295250678
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 97-0471
• Device Catalogue Number: 970471
• Device Lot Number: 461816
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention