MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA VIVACIT-E ULTRACONGRUENT ARTICULAR SURFACE LEFT 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: persona cruciate retaining cemented narrow femoral component left size 8, catalog #: 42502006401, lot #: 64411236; persona vivacit-e ultracongruent articular surface left 10mm catalog #: 42512200510, lot #: 64444903.Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address patella and medial ligament instability approximately nineteen (19) months 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of pictures provided showed cement and bone ingrowth on the bottom of the tibial tray and femoral component.The device history records were reviewed and no discrepancies were identified.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA VIVACIT-E ULTRACONGRUENT ARTICULAR SURFACE LEFT 10MM
• 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: 12778657
• Report Number: 3007963827-2021-00284
• Device Sequence Number: 17627740
• Product Code: MBH
• UDI-Device Identifier: 00889024236523
• UDI-Public: (01)00889024236523(17)241031(10)64444903
• 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: 2020
• 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
• Report Date (Section B): 02/25/2022

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: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42512200510
• Device Lot Number: 64444903
• 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: 10/19/2021
• Supplement Date Received by Manufacturer: 11/09/2021; 02/22/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 11/30/2021; 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 80 KG