MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN CONST TASP SHIM GH 12MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04235, 0001822565-2019-04282, 0001822565-2019-04283.

Event Description

It was reported that the tibial articulation surface provisional shims were returned as worn and missing ball bearing.No additional information is available.

Manufacturer Narrative

Visual examination of the returned products confirms the tasp shims are missing bearings as well as exhibit signs of repeated use.Device history record was reviewed and no discrepancies were found.This was previously investigated through the capa process which determined the cause was related to the device design, which was modified as a result.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information reported.

• Brand Name: PSN CONST TASP SHIM GH 12MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9152386
• MDR Text Key: 164271383
• Report Number: 0001822565-2019-04281
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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: 42527900602
• Device Lot Number: 62967513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1052-2015
• Patient Sequence Number: 1