MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CRUCIATE RETAINING STANDARD FEMORAL COMPONENT RIGHT SIZE 10; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577); Joint Impingement (4834)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision approximately one (1) year post-operatively to address pain, instability, swelling, quadriceps contraction and posterior cruciate ligament (pcl) deficiency with impingement.Initial operative notes noted no intraoperative complications.Revision operative notes noted the patient was diagnosed with global instability with pcl deficiency and severe arthrofibrosis with impingement and hypertrophic scar.The patient had persistent pain, instability and swelling since initial surgery with quadriceps contraction and unable to perform straight leg raise without lag.There was a deficiency of the posterior cruciate ligament with flexion instability.Inspection revealed the implants were well-positioned and well-fixed with no signs of poly wear or loosening.There was significant scarring within the joint space, suprapatellar space, gutters, as well as encapsulation of almost the entire polyethylene of the patella.All components were removed and replaced except the patella without complications.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
Cmp (b)(4).D10 - concomitant devices - persona medial congruent articular surface right 11mm catalog #: 42522100811 lot #: 65552664, persona cemented stemmed tibial component right size f catalog #: 42532007502 lot #: 65440949, persona cemented all poly patella 32mm catalog #: 42540000032 lot #: 65737320.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.
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 and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: h4.H6 - component code - proposed code is mechanical (g04) - femur medical records provided confirmed the reported event.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.

• Brand Name: PERSONA CRUCIATE RETAINING STANDARD FEMORAL COMPONENT RIGHT SIZE 10
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• 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: 20886335
• Report Number: 3007963827-2024-00492
• Device Sequence Number: 7842867
• Product Code: JWH
• UDI-Device Identifier: 00889024230422
• UDI-Public: (01)00889024230422(17)320403(10)65328773
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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 Model Number: N/A
• Device Catalogue Number: 42502606802
• Device Lot Number: 65328773
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White