MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA STEMMED TIBIAL COMPONENT SIZE C RIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Implant subsidence (4078)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Arthralgia (2355); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona posterior stabilized standard nitrided cemented femoral component catalog #: 42570605802 lot #: 65120662, persona posterior stabilized articular surface right 12mm catalog #: 42522400412 lot #: 64093960, persona cemented all-poly patella 32mm catalog #: 42540000032 lot #: 65299731.The complainant has indicated that the product will not be returned to zimmer biomet for investigation as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address continued pain, instability and aseptic loosening and subsidence of the tibial component approximately three (3) years post-operatively.Clinical notes from the patient's initial procedure noted no intraoperative complications.Clinical notes from the patient's revision noted the tibial stem had subsided and migrated laterally with a defect laterally in the proximal tibia.The femoral component was found to be stable and was retained as well as the patella.No intraoperative complications were noted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: b5, h6.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.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address continued pain, instability, and subsidence of the tibial component approximately three (3) years post-operatively.Clinical notes from the patient's initial procedure noted no intraoperative complications.Clinical notes from the patient's revision noted the tibial stem had subsided and migrated laterally with a defect laterally in the proximal tibia.The femoral component was found to be stable and was retained as well as the patella.No intraoperative complications were noted.
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 following sections were updated: b4, g3, g6, h2, h3, h6, h11.The product was evaluated through manufacturing review and medical records 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 STEMMED TIBIAL COMPONENT SIZE C RIGHT
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22841229
• Report Number: 3007963827-2025-00323
• Device Sequence Number: 9580827
• Product Code: MBH
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2026

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532006402
• Device Lot Number: 64093960
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 05/28/2026
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 11/21/2025; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2018
• 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; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 291 LB
• Patient Race: Black Or African American