MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Muscle/Tendon Damage (4532)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient fell & ruptured pcl.It was not the opinion of the hcp or patient that the fall was related to the implants.The poly was exchanged with an increased thickness & uc for stability.Mc to uc and thicker poly to make up for pcl deficit and improved stability.
Additional Manufacturer Narrative
(b)(4).G2:australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Insufficient information provided.Unable to perform a compatibility check.An adequate complaint history review cannot be performed as the failure mode experienced by the user is unknown.Medical records were not provided.This complaint cannot be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM
• 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: 18912733
• Report Number: 3007963827-2024-00075
• Device Sequence Number: 6892945
• Product Code: JWH
• UDI-Device Identifier: 00889024469464
• UDI-Public: (01)00889024469464(17)240831(10)64403822
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42512101011
• Device Lot Number: 64403822
• Was Device Available for Evaluation?: No
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male