MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE CEMENTED FEMORAL COMPONENT SIZE 6 RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - persona partial knee cemented tibial component size f right medial catalog #: 42538000602 lot #: ni, persona partial knee articular surface right medial size f 8mm catalog #: 42528200608 lot #: ni.Report source - foreign: (b)(6).The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2022-00651, 0001825034-2022-00652.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address instability and aseptic loosening of the tibial and femoral components nearly three (3) years post-operatively.Attempts have been made, however, no additional information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6 - component code mechanical (g4) femur.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information provided.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.D10 - concomitant devices - persona partial knee cemented tibial component size f right medial catalog #: 42538000602 lot #: 64119546, persona partial knee articular surface right medial size f 8mm catalog #: 42528200608 lot #: 63887349.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address pain, instability and suspected loosening of the tibial and femoral components nearly three (3) years post-operatively.During the revision, hemarthrosis and evidence of trauma were identified, however, the components were well-fixed.None of the implants were visibly damaged and there was no evidence of infection and only early evidence of degenerative change elsewhere in the knee.Attempts have been made, however, no additional information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: type of investigation - insufficient information available is n/a which was reported on initial report.Investigation findings - device migration is n/a which was reported on initial report.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Additional information does not affect previous the root cause.Medical records review indicates (b)(6) 2020 patient fell onto flexed knee, reports pain; (b)(6) 2021 revision: conversion to nexgen components, components were not obviously loose and need to be removed with osteotomes; (b)(6) 2022 from per instability.Radiographs review indicates there is mild osteopenia.Overall fit of the hardware is appropriate.No bony fracture.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.

• Brand Name: PERSONA PARTIAL KNEE CEMENTED FEMORAL COMPONENT SIZE 6 RIGHT MEDIAL
• Common Device Name: PROSTHESIS, 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: 13901611
• Report Number: 0001825034-2022-00650
• Device Sequence Number: 17292183
• Product Code: HSX
• UDI-Device Identifier: 00880304808577
• UDI-Public: (01)00880304808577(17)280531(10)63947491
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000602
• Device Lot Number: 63947491
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 08/16/2022; 08/25/2022; 12/29/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 08/18/2022; 09/16/2022; 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 105 KG