MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT TRAY SLEEVE POR M/L 29MM; MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY

Model Number	1294-54-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	04/26/2020
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 to address pain, distal femur fracture, flexion instability and tibial loosening at the bone to cement interface due to fall.Cement manufacturer is unknown.It was also reported that the patient had a prior right knee revision done sometime within the last 10 years in poway, ca for tibial loosening.The surgeon told the sales rep that from looking at the x-ray his plan was to nail the femur thru the sigma cr femur.He also said that he believes the tibial component also became loose after the fall, so he wanted to revision the tibia.He said the patient never complained of pain or instability before the fall, even though under his exam, the patient had a lot of flexion instability.He felt like he needed to add thickness to the already thick tray the patient currently had in.The surgeon in california, didn't use a stem with his revision tibia.The surgeon nailed the femur, then removed the loose tibial component with ease.He ended up using the next size tibial sleeve (37mm), putting in a 115x14 pressfit stem, and went with the 25mm thick tray and a 10mm insert.He was happy with the stability and with how the fracture was nailed.Doi: last 10 years; dor: (b)(6) 2020; right 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.  product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT TRAY SLEEVE POR M/L 29MM
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10030814
• Report Number: 1818910-2020-11783
• Device Sequence Number: 3696471
• Product Code: NJL
• UDI-Device Identifier: 10603295026402
• UDI-Public: 10603295026402
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/26/2020

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: 1294-54-000
• Device Catalogue Number: 129454000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT REV TIB TRAY SIZE 3 15MM; MBT TRAY SLEEVE POR M/L 29MM; PFC SIGMARP CV TB/IN S3 17.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR