MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR); PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: persona femur trabecular metal cruciate retaining (cr) catalog # 42502806002, lot # 64339760; persona natural tibia trabecular metal two-peg porous fixed bearing catalog # 42530006702, lot # 64611234; nexgen all poly patella catalog # 00597206526, lot # 64774827; headed screw 48 mm length catalog # 00579104100, lot # 64306448; headed screw 48 mm length catalog # 00579104100, lot # 64744162; patella reamer blade with pilot hole 26 mm diameter single use only catalog # 00597909526, lot # 64704876.2.5 mm female hex screw 25 mm length catalog # 42509902525, lot # 64937354; depuy cmw bone cement catalog # 3322-040, lot # 9552288.Report source: (b)(6).Customer has indicated that the product will not be returned because it was scrapped.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2021-02791 0001822565-2021-02793.Discarded.
Event or Problem Description
It was reported patient underwent a revision procedure seven months post implantation due to pain and swelling.During revision procedure, surgeon noted clear synovial fluid, but that synovium was inflamed and sent tissue biopsy¿s for evaluation.He also noted that there was very little bone in growth in the tibial base plate and femur prosthesis.Attempt for further information has been made, but no further information has been provided.
Additional Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Visual evaluation of the provided pictures shows femoral and tibial implants covered with tissues.Tibial was missing one of the pegs and damages look like happened during explanations.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.X-ray review indicates anatomic alignment of the right knee arthroplasty.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 FIXED BEARING CRUCIATE RETAINING (CR)
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12561543
• Report Number: 3007963827-2021-00222
• Device Sequence Number: 1348896
• Product Code: JWH
• UDI-Device Identifier: 00889024241558
• UDI-Public: (01)00889024241558(17)240930(10)64425860
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 01/19/2022

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: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42522000410
• Device Lot Number: 64425860
• 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: 09/07/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2019
• 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 Sex: Female