MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIB TRAY SIZE 4 25MM; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Catalog Number	129435425
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/25/2017
Type of Reportable Event	Serious Injury
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.Occupation: is a non-healthcare professional.(b)(4).
Event or Problem Description
On (b)(6) 2017, the patient underwent a left knee revision due to loosening, instability, dislocated polyethylene, footdrop and extensor mechanism compromise.The surgeon noted the polyethylene insert was completely dislocated.The patient was implanted with depuy knee system and competitor¿s cement.There were no complications reported with the procedure.Doi: (b)(6) 2015 (patellar and femoral components).Doi: (b)(6) 2017 (tibial tray, insert and bone cement).Dor: (b)(6) 2017 (lt knee).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision depuy synthesof 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.Product complaint # (b)(4).Investigation summary = > the device associated with the reported event was not returned to the investigation site for evaluation.Depuy synthes considers the investigation closed at this time.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: MBT REV TIB TRAY SIZE 4 25MM
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9260700
• Report Number: 1818910-2019-113340
• Device Sequence Number: 17127284
• Product Code: NJL
• UDI-Device Identifier: 10603295026051
• UDI-Public: 10603295026051
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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 Expiration Date: 12/31/2024
• Device Catalogue Number: 129435425
• Device Lot Number: 616245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR