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 Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Joint Laxity (4526); Muscle/Tendon Damage (4532); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42502606402 - femur cemented cruciate retaining (cr) standard right size 8 - unknown 42532006702 - tibia cemented 5 degree stemmed right size d - unknown 42540200029 - all-poly patella cemented 29 mm diameter - unknown g2 : foreign country : australia customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Approximately 3 years post-op, the patient was revised due to instability, effusion, ho, and osteopenia.During the revision, the surgeon noted a posterior capsule and ruptured pcl with the femur translation posteriorly causing the knee to be out of alignment.The poly had excessive wear and the posterior edge was broken off.The poly was exchanged.The femur, tibia, and patella remain implanted.Attempts have been made and all available information has been provided.
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.The event is confirmed.Visual examination of the provided pictures identified heavy condyle wear with gouges and material missing.The implant is also coated in a foreign material.As the device was not returned further evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified that ct imaging revealed no lucency or dislocation, small effusion, chronic presumed heterotopic calcification in suprapatellar pouch, generalized osteopenia, moderate degeneration of the proximal tibiofibular joint.During the revision, the posterior capsule and pcl were compromised due to a ¿movement conflict¿.There was excessive wear to the poly seen along with a broken posterior edge of the poly.The femur was translating posteriorly due to a posterior capsule and ruptured pcl and the flexion space opened causing excessive imbalance.The patient has a history of the opposite ankle/foot being fused and excessive forces driving out of a seated position had been applied to this knee.It is unknown when the pcl ruptured in comparison to the wear found on the articular surface.Also is it unknown how much excessive forces are created by the opposite fused ankle, as such a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• 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
• 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: 20912021
• Report Number: 3007963827-2024-00502
• Device Sequence Number: 18104294
• Product Code: MBH
• UDI-Device Identifier: 00889024241558
• UDI-Public: (01)00889024241558(17)250430(10)64649945
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 03/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 42522000410
• Device Lot Number: 64649945
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female