MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM; 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)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the device was discovered to have missing components before surgery.Another device was used to complete the surgery.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the device was discovered to have missing components before surgery.Another device was used to complete the surgery.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of repeated use and one of the components 42527991001 and 42527991002 has disassembled.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A field action was initiated 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.The fractured tasp component in this complaint was manufactured before the design modification.The root cause is considered to be a previously addressed design issue.The event is being reviewed through the capa process.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM
• Common Device Name: INSTRUMENT 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: 13474787
• Report Number: 0001822565-2022-00268
• Device Sequence Number: 11794504
• Product Code: JWH
• UDI-Device Identifier: 00889024245877
• UDI-Public: (01)00889024245877(10)62627301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 42527900503
• Device Lot Number: 62627301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2014
• 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: Z-1052-2015
• Patient Sequence Number: 1
• Patient Sex: Unknown