MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CRUCIATE RETAINING CEMENTED STANDARD FEMORAL COMPONENT RIGHT SIZE 9; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Radiolucent Lines (4848)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona ultracongruent articular surface right 10mm catalog #: 42522200510 lot #: 63042815, persona cemented stemmed tibial component right size f catalog #: 42532007502 lot #: 63118706, persona cemented tapered stem extension 14mm x +30mm catalog #: 42557000114 lot #: 63135449, palacos rg bone cement 1x40 single catalog #: 00111314001 lot #: 80934425, persona all-poly cemented patella 32mm catalog #: 42540200032 lot #: 63049977.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0002648920-2024-00072, 0002648920-2024-00073, 0001822565-2024-00921, 0001822565-2024-00922 h3 other text : investigation incomplete.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address pain, arthrofibrosis, stiffness, limited range of motion, radiolucency and tibial and femoral implant loosening approximately five (5) years following right knee arthroplasty.In the months and years following the revision, the patient continued to progress and pain resolved.Initial operative notes noted no intraoperative complications.Revision operative notes noted under the indication for the procedure, "the patient did have severe arthrofibrosis with an arc of motion of about 40 degrees as well as radiographic evidence of loosening of both [the] femoral and tibial components." during the procedure, notes noted, "there was severe arthrofibrosis throughout the anterior compartment as well as medial and lateral gutters.No bone loss during removal of [the femoral component].It did take quite a bit of time to expose the tibial component secondary to [the] severe arthrofibrosis.There were no fractures encountered and absolutely no bone loss was encountered during tibial component removal." all components were removed and 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.Updated.Proposed component code: mechanical (g04) - femur.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: on (b)(6) 2020 exam, contracture and instability in the coronal and sagittal plane confirmed, severe pain, 5-10 degree flexion contracture, total flexion 61-65 degrees, severe stiffness; revision surgery: all components removed required osteotome and saw release to implants.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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 CRUCIATE RETAINING CEMENTED STANDARD FEMORAL COMPONENT RIGHT SIZE 9
• 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: 18932271
• Report Number: 3007963827-2024-00074
• Device Sequence Number: 4449974
• Product Code: JWH
• UDI-Device Identifier: 00889024230408
• UDI-Public: (01)00889024230408(17)250131(10)62956222
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 42502606602
• Device Lot Number: 62956222
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White