MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CPS 10MM ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42532007102, tibia cemented 5 degree stemmed right size e, 66718845.42500606802, ps cemented femoral component, 66279749.G2: foreign - event occurred in australia.The complaint was confirmed.Visual examination of the provided pictures identified the articular surface has a condyle that is heavily worn.As the device was not returned, further evaluations could not be performed.Review of the device history records identified no related deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total knee arthroplasty with cemented components and dissociation of the tibial polyethylene insert.Tibial component undersizing is noted, including substantial undercoverage of the medial and posterior tibial plateau by the tibial component, which is positioned laterally and anteriorly in relation to the tibial anatomic axis.A definitive root cause cannot be determined.
Event or Problem Description
It was reported that the patient underwent an initial tka.Subsequently, a revision was performed approximately 14 months post-implantation due to component dissociation.Attempts have been made and no further information has been provided.

• Brand Name: PERSONA CPS 10MM ARTICULAR SURFACE
• 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: 25595319
• Report Number: 3007963827-2026-00270
• Device Sequence Number: 5382139
• Product Code: MBH
• UDI-Device Identifier: 00889024244641
• UDI-Public: (01)00889024244641(17)290305(10)66570246
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 42522600810
• Device Lot Number: 66570246
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• 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; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male