MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT POR TIBIAL TRAY SZ2; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Model Number	1294-32-120
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	12/10/2019
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
Update 20 dec 2019.Medical records were reviewed to identify patient harms/product issues.On (b)(6) 2019, the patient presented for a left knee evaluation due to pain, decreased range of motion, instability, and difficulty walking following a fall.The physician suspected a possible tibial bone fracture and possible patellar tendon injury.An x-ray of the left knee revealed a valgus alignment of about 3 degrees as well as a small sclerotic area on the tibia.The physician indicated the patient would undergo an mri to rule out possible injuries.The patient was put in a knee immobilizer and given crutches.The primary operative note indicated two depuy cement products were used during the primary operation.There is no evidence of revision or invasive intervention.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 will be filed as appropriate.

• Brand Name: MBT POR TIBIAL TRAY SZ2
• 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: 9553908
• Report Number: 1818910-2020-00608
• Device Sequence Number: 16252823
• Product Code: NJL
• UDI-Device Identifier: 10603295025672
• UDI-Public: 10603295025672
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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: 1294-32-120
• Device Catalogue Number: 129432120
• Device Lot Number: 8004988
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 63