MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA CEMENTED ALL-POLY PATELLA 32MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address severe pain, swelling, instability, difficulty performing daily activities and difficulty straightening the right leg approximately four (4) months post-operatively, despite home exercises and therapy.Initial operative notes noted no intraoperative complications, however, the patient was additionally treated intravenously five (5) days post-operatively for cellulitis.Revision operative notes noted the patient had obvious valgus alignment of the tibial component, however, all components were found to be well-fixed and no wear or damage was seen with the patella.The patient's range of motion at the end of the procedure was 0-125 degrees.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona cruciate retaining cemented narrow femoral component right size 6 catalog #: 42502006002 lot #: 64468330, persona cemented stemmed tibial component right size d catalog #: 42532006702 lot #: 64374539, persona ultracongruent articular surface right 13mm catalog #: 42522200413 lot #: 63551523, persona stem extension tapered cemented 14 mm diameter +30 mm length catalog #: 42557000114 lot #: 64529728 the complainant has indicated that the product will not 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: 3007963827-2023-00161, 3007963827-2023-00162, 0001822565-2020-00460, 0002648920-2023-00121 and 0001822565-2023-01623.This report was previously submitted erroneously on feb 6, 2020 and jun 10, 2020 under manufacturing report number 0001822565-2020-00461.H3 other text : investigation incomplete.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records provided and previously reported confirm the reported event.The device history records were reviewed and no discrepancies were identified.The reported infection was found to not be related to the device, however, 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 CEMENTED ALL-POLY PATELLA 32MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17133988
• Report Number: 0002648920-2023-00121
• Device Sequence Number: 15312014
• Product Code: MBH
• UDI-Device Identifier: 00889024247697
• UDI-Public: (01)00889024247697(17)240930(10)64516140
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42540200032
• Device Lot Number: 64516140
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• 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: 62 KG