MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING CR LEFT 13 MM HEIGHT; PROSTHESIS, KNEE

Model Number	42-5110-004-13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: germany.The customer has indicated that the product is in the process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow up mdr will be submitted.H3 other text : see h10 narrative.
Event or Problem Description
It was reported that during an initial left total knee arthroplasty, the articular surface fractured during the function check.The articular surface was then removed and placed with another device.No adverse events or patient impact has been reported as a result of the malfunction.It was reported that no further information is available.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
Visual examination of the returned product identified the locking features to exhibit damage (flared out) and the distal surface exhibits damage (nicked / gouged) in various areas most likely from removal from the joint space.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that no problem was found with the device.As returned it exhibits signs of use in the form of being inserted and being locked in.A crack was not found.This complaint is not confirmed.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: ARTICULAR SURFACE FIXED BEARING CR LEFT 13 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16844999
• Report Number: 3007963827-2023-00098
• Device Sequence Number: 6870038
• Product Code: MBH
• UDI-Device Identifier: 00889024233140
• UDI-Public: (01)00889024233140(17)250430(10)63634749
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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 Expiration Date: 04/30/2025
• Device Model Number: 42-5110-004-13
• Device Catalogue Number: 42511000413
• Device Lot Number: 63634749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose