MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE LEFT 14MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Ambulation or Postural Difficulties (2544); Hyperextension (4523); Joint Laxity (4526)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address pain, stiffness, popping sensations, ligament laxity, instability and limited ability to perform daily activities approximately fifteen (15) months post-operatively.The articular surface and femoral component were revised and replaced and a tibial stem added.Initial operative notes noted no intraoperative complications.The patient was discharged on (b)(6) 2022 with at home therapy.Revision operative notes noted the patient's pain began approximately six (6) months prior, limiting daily activity, and the patient was also experiencing instability.During the procedure, severe varus-valgus laxity and hyperextension were noted.The femoral component was in good alignment and removed without difficulty.Sclerotic and non-viable bone required removal from the femur prior to placing the new femoral component.A sequentially larger articular surface was used to achieve stability and the tibial baseplate was punched to accommodate the tibial stem.No intraoperative complications were identified.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona cemented narrow cruciate retaining femoral component left size 8 catalog #: 42502006401 lot #: 64985214, persona cemented stemmed tibial component left size e catalog #: 42532007101 lot #: 65284106, persona cemented all poly patella 38mm catalog #: 42540000038 lot #: 65351864 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: 3007963827-2023-00301, 3007963827-2023-00302.H3 other text : investigation incomplete.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain for 6 months, limiting adl, instability, varus-valgus laxity, hyperextension, sclerotic and non viable bone removed in revision.It was noted in the op noted that a tibial stem was added however a new tibial plate was not.A definitive root cause cannot be determined.While reviewing the provided op notes it is possible that the original tibial plate was re-used.Ifu 87-6204-022-23 rev b states 'this device is for single use only, do not reuse.Reuse of a single use device that has come into contact with blood, bone, tissue or other body fluids may lead to patient or user injury.Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents'.Reusing implants is against the ifu.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 MEDIAL CONGRUENT ARTICULAR SURFACE LEFT 14MM
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18061912
• Report Number: 3007963827-2023-00302
• Device Sequence Number: 20490404
• Product Code: MBH
• UDI-Device Identifier: 00889024469334
• UDI-Public: (01)00889024469334(17)250714(10)64766460
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: 07/14/2025
• Device Model Number: N/A
• Device Catalogue Number: 42512100814
• Device Lot Number: 64766460
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2020
• 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