MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEM EXTENSION STRAIGHT SPLINED UNCEMENTED; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient was experiencing pain, inability to bear weight, and feelings of the knee giving way one year post implantation and was instructed to continue physical therapy and home exercises.Further, patient had an unknown fall that resulted in a contralateral femoral fracture and was prescribed rehabilitation.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: femur cemented, catalog #: 42504607012, lot #: 64890244.Articular surface fixed bearing constrained posterior stabilized (cps), catalog #: 42522600816, lot #: 64781777.Stem extension, catalog #: 42560113518, lot #: 64835221.Tibia fixed cemented, catalog #: 42542007502, lot #: 65016894.Tibial augment cemented, catalog #: 42555805410, lot #: 64925231.Tibial augment, catalog #: 42555805210, lot #: 64963266.H3: customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: a1, b5, b7, d2, e1, g1, g3, g6, h1, h2.
Event or Problem Description
It was reported patient was experiencing pain, inability to bear weight, and feelings of the knee giving way one year post implantation and was instructed to continue physical therapy and home exercises.Further, patient had an unknown fall that resulted in a contralateral femoral fracture and was prescribed rehabilitation.Attempts to obtain additional information have been made; however, no more is available at this time.The operative findings noted that revision due to femoral implant loosening, mild flexion instability, general anesthesia + block x2, mild flexion instability, patella well fixed and remains intact, no gross loosening of the femoral or tibial components and removed without difficulty, no signs of infection, rom with trial components good, permanent components placed with bone cement, no intra-op complications/events, aspirin for dvt prophylaxis, dc with op rehabilitation.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: b4, b5, b6, d2, g1, g3, g6, h1, h2.
Event or Problem Description
No further event information available at the time of this report.
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, b5, g4, g7, h1, h2, h3, h6, h9, h10.H6: suggested component code: mechanical (g04) - stem.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates there is mild pain; fall due to unknown reasons, contralateral femur fracture, and no indication of loosening.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 STEM EXTENSION STRAIGHT SPLINED UNCEMENTED
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19719792
• Report Number: 0001822565-2024-02323
• Device Sequence Number: 18224696
• Product Code: JWH
• UDI-Device Identifier: 00887868249822
• UDI-Public: (01)00887868249822(17)300331(10)64707584
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/26/2024

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: 42560113516
• Device Lot Number: 64707584
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 09/05/2024; 12/17/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/12/2024; 09/10/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2020
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 128 KG