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

Model Number N/A

Device Problem Disassembly (1168)

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

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03208 and -03210.

Event Description

It was reported that during cleaning after surgery the ball bearing from the tasp was missing.There was no patient involvement.

Manufacturer Narrative

The complaint sample was evaluated and the reported event was confirmed through physical evaluation.The returned provisional shims each exhibited signs of use and were each missing one ball bearing.The missing ball bearings were not returned for evaluation.The device history records were reviewed and no discrepancies were identified.A corrective and preventative action investigation for this issue initiated a field action to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.The device was subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that this device was manufactured prior to this design change.Therefore, the root cause is attributed to be the aforementioned design issue.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: TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7595755
• MDR Text Key: 110868256
• Report Number: 0001822565-2018-03209
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: PK113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42527900504
• Device Lot Number: 62315467
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: ZFA 2014-67, Z-1052-2015
• Patient Sequence Number: 1