MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POSTERIOR REFERENCING SIZER; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

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.

Event Description

It was reported that the ball bearing fell out of the top of the persona p-ref sizer so the boom won't click in for accurate sizing.This happened during the wash cycle.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product confirms that the ball bearing was missing from the instrument.Also, the instrument shows discoloration and nicks which can be related to repeated use.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.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.

• Brand Name: POSTERIOR REFERENCING SIZER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11078414
• MDR Text Key: 223811601
• Report Number: 0001822565-2020-04223
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024232556
• UDI-Public: (01)00889024232556
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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: 42509904000
• Device Lot Number: ZB6703400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1