MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 fractured tasp was found in spd.

Manufacturer Narrative

Cmp-(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: reported event was confirmed by review of actual device received.Device history record (dhr) was reviewed and the following supplier found 1 anomaly for 43 parts scrapped in operation 20 due to tight tolerance on post profile.This anomaly would not have caused or contributed to the reported event as the affected units were scrapped.A definitive root cause cannot be determined as the frequency and condition of use are unknown.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

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

• Brand Name: CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8095839
• MDR Text Key: 128080287
• Report Number: 0001822565-2018-06507
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42517600505
• Device Lot Number: 62563913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/21/2018
• Supplement Dates Manufacturer Received: 12/27/2018
• Supplement Dates FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1