MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SYNATOMIC VF TIB CLIP; KNEE TIBIAL INSERT ACCESSORY

Catalog Number	118830000
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	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 code(s) 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.Corrective action was not indicated.(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
Planned revision tkr on (b)(6) 2019 for a sas.Revision was performed due to anterior knee pain.

• Brand Name: SYNATOMIC VF TIB CLIP
• Common Device Name: KNEE TIBIAL INSERT ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9569255
• Report Number: 1818910-2020-01239
• Device Sequence Number: 16280330
• Product Code: KYK
• UDI-Device Identifier: 10603295008354
• UDI-Public: 10603295008354
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K851341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2019

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 Catalogue Number: 118830000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/09/2020
• 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