MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS); 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
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.
Additional Manufacturer Narrative
(b)(4).Medical product: persona femur cemented posterior stabilized (ps) catalog # 42500605602 lot # 62403933.Stem extension tapered cemented 14 mm diameter +30 mm length catalog # 42557000114 lot # 63094419.Persona tibia cemented stemmed catalog # 42532006402 lot # 63066334.Stem extension tapered cemented catalog # 42557000114 lot # 63094419.2.5 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: 0001822565-2022-02838, 3007963827-2022-00114, 0001822565-2022-02838, 0001822565-2022-01242, 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.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.H10: h6 - component code: mechanical (g04) - stem is n/a which was reported on final report.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS)
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15533930
• Report Number: 0001822565-2022-02842
• Device Sequence Number: 7838496
• Product Code: MBH
• UDI-Device Identifier: 00889024243521
• UDI-Public: (01)00889024243521(17)200229(10)62981928
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• 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,Followup
• Report Date (Section B): 10/05/2022

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: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 42522400411
• Device Lot Number: 62981928
• 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
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female