MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA CEMENTED STEMMED; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Subclinical Infection (2247)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: persona femur cemented posterior stabilized (ps), catalog #: 42500605602, lot #: 62403933.Stem extension tapered cemented 14 mm diameter +30 mm length, catalog #: 42557000114, lot #: 63094419.Articular surface fixed bearing posterior stabilized (ps) right 11 mm height, catalog #: 42522400411, lot #: 62981928.2.5 mm female hex screw 25 mm length, catalog #: 42509902525, lot #: 63120520.Headless trocar drill pin 3.2 mm diameter 75 mm length, catalog #: 00590102000, lot #: 63154945.All poly pat ve 32 mm dia, catalog #: 42540200032, lot #: 62805858.Multiple mdr reports were filled for this event: 3007963827-2022-00114, 0001822565-2022-02838, 0001822565-2022-02842, 0002648920-2022-00206.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.A definitive root cause cannot be determined.Medical records review indicates serial bone scan indicated progressive loosening of the patient¿s components, normal appearing synovial fluid, poly in excellent condition, no gross loosening of the components, tibia well fixed, the cement implant interface and the bone implant interface of the femoral component seemed to be somewhat compromised, procedure completed without further complications or significant findings.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
It was reported patient underwent a revision procedure seven years post implantation due to pain and tibial loosening.The patient was suspected and treated for subclinical occult infection.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: PERSONA TIBIA CEMENTED STEMMED
• 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: 15530862
• Report Number: 0001822565-2022-01242
• Device Sequence Number: 2507357
• Product Code: JWH
• UDI-Device Identifier: 00889024471023
• UDI-Public: (01)00889024471023(17)250531(10)63066334
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2022

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 42532006402
• Device Lot Number: 63066334
• 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: 09/12/2022
• Initial Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• 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 Sex: Female