MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD 360 KNEE STYSTEM OSSEOTI TIBIAL SLEEVE AUGMENT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Migration (4003)

Patient Problem No Information (3190)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 185264 lot # 2924013 vanguard ssk 360 femoral with screw.Item # 185324 lot # 346730 vanguard 360 distal femoral augment 65mm.Item # 185344 lot # 088920 vanguard 360 posterior augment 65mm with bolt.Item # 185384 lot # 002180 vanguard 360 distal femoral augment 10mm x 65mm with bolt.Item # 148307 lot # 877190 splined knee system v2 17mm x 80mm.Item # 185210 lot # 524220 360 offset adaptor 2.5mm with screws.Item # 185203 lot # 289980 360 tibial tray with ti locking bar and screw 71mm.Item # 148287 lot # 795740 splined knee system v2 12mm x 40mm.Item # 185212 lot # 902910 360 offset adaptor 7.5mm with screws.Item # 183880 lot # 911630 vanguard dcm tibial bearing 10mm x 71 75 mm.Stryker simplex bone cement.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01403, 0001825034-2019-01404, 0001825034-2019-01405, 0001825034-2019-01406, 0001825034-2019-01407, 0001825034-2019-01408, 0001825034-2019-01412, 0001825034-2019-01413, 0001825034-2019-01414, 0001825034-2019-01416.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient underwent an initial knee procedure and three years after the procedure the patient was revised due to instability and loosening.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.This complaint was not confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The medical records provided were not further reviewed by the nursing team as they contained minimal information.Additional medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VANGUARD 360 KNEE STYSTEM OSSEOTI TIBIAL SLEEVE AUGMENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8456334
• MDR Text Key: 140008075
• Report Number: 0001825034-2019-01415
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K140883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 185551
• Device Lot Number: 058470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 76