MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL ART SUR PROVISIONAL SHIM GH 10 MM; INSTRUMENT KNEE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (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 or Problem Description
It reported that the instrument is missing one ball bearing.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of the returned item found it to exhibit signs of repeated use and have both of components 42527991001 and 42527991002 disassembled / missing from the device.The components were not returned.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Field actions were initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.These devices were subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that these devices were manufactured prior to this design change.The root cause is considered to be a previously addressed design issue.This complaint can be confirmed based on returned device with missing bearings.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h3, h4, h6, h9 and h11.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: PERSONA TIBIAL ART SUR PROVISIONAL SHIM GH 10 MM
• Common Device Name: INSTRUMENT KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19403447
• Report Number: 0001822565-2024-01739
• Device Sequence Number: 17881400
• Product Code: JWH
• UDI-Device Identifier: 00889024245945
• UDI-Public: (01)00889024245945(10)62121525
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42527900700
• Device Lot Number: 62121525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ZFA 2014-67; Z-1052-2015
• Patient Sequence Number: 1
• Patient Sex: Unknown