MAUDE Adverse Event Report: ZIMMER TMT PERSONA FEMORAL CENTRAL CONE SIZE SMALL; PROSTHESIS, KNEE

Catalog Number	42545001011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent right knee a two-stage revision for infection.Approximately seven months later the patient began to have intermittent pain and swelling.Two years and five months later the patient reported an increase in pain and was prescribed physical therapy.All implants remain in place.
Additional Manufacturer Narrative
(b)(4).D10- medical product: persona femur cemented plus right size 7+, item# 42504606212, lot# 64767893.Persona stem ext straight spld uncemented 16mm dia +135mm l.Item# 42560113516, lot# 64783575.Persona femoral distal augment cemented size 7, 7+ 5mm.Item# 42556606205, lot# 64859431.Persona tibia fixed cemented right size d, item# 42542006702, lot# 64565801.Persona stem ext 3mm offset spld uncemented 12mm dia +135mm l.Item# 42560313512, lot# 64675872.Persona articular surface fixed bearing (cps) right 16mm.Item# 42522600516, lot# 64647943.Persona tibial central cone size medium, item# 42545000512, lot# 64680480.Nexgen complete knee solution trabecular metal std patella.Item# 00587806532, lot# 64227939.Unk palacos cement.H10: this device was erroneously reported under an incorrect mfr, and is now being submitted under the appropriate mfr.See original report 0001822565-2024-01318.No products were returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Office notes were provided and report pain, swelling and trouble ambulating.The patient also reported fall on ice.X-rays taken during visit state no periprosthetic fracture and implants are well positioned.X-rays reviewed over two months during which shows a stable appearance of revision components.The patient reports increasing right knee pain resulting in physical therapy.Review of the device's history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This complaint is not confirmed.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 FEMORAL CENTRAL CONE SIZE SMALL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25045531
• Report Number: 3005751028-2026-00040
• Device Sequence Number: 13174819
• Product Code: JWH
• UDI-Device Identifier: 00889024560789
• UDI-Public: (01)00889024560789(17)300331(10)64643091
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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
• Device Catalogue Number: 42545001011
• Device Lot Number: 64643091
• 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: 04/30/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White