MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 8; PROSTHESIS, KNEE

Catalog Number	42500606402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: articular surface fixed bearing constrained posterior stabilized (cps) right 12 mm height: catalog#42522600512, lot#65347114; tibia cemented 5 degree stemmed right size d: catalog#42532006702, lot#66188147; stem extension tapered cemented 14 mm diameter +30 mm length: catalog#42557000114, lot#66010463; all poly patella cemented 32 mm diameter: catalog#42540000032, lot#65977769; refobacin plus bone cem 2x20-3: catalog#3021180001-3, lot#x02aai0105; refobacin plus bone cem 2x40-3: catalog#3021170001-3, lot#ax42ek2502, qty#2 g2: foreign: germany the product will not be returned to zimmer biomet for evaluation as the device remains implanted.The investigation is in progress.H3 other text : see h10 narrative.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, three (3) weeks post-implantation, the patient presented with progressive knee pain with activity.The patient's range of motion was limited and ambulation was only possible with use of a wheelchair.Diagnostic x-rays revealed a periprosthetic fracture in the medial femoral condyle and the patient was hospitalized for pain therapy and plaster cast fracture stabilization.Due diligence is complete as multiple attempts have been made; all available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10.H6: proposed component code: mechanical (g04) - femur.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: rehab notes three weeks post-implantation: pain is activity induced and is not present at rest or at night, mobilization is only possible in a wheelchair, patient admitted for pain therapy, transferred to ortho for fracture stabilization (plaster treatment) radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single ap knee labeled "undated" demonstrates a vertically oriented periprosthetic fracture of the medial distal femur.There is no evidence of implant loosening.Alignment is anatomic.Bone quality is mildly osteopenic.Root cause was unable to be determined.Reported event was confirmed by review of provided medical records and radiographs.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 8
• 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: 18595537
• Report Number: 3007963827-2024-00021
• Device Sequence Number: 17845110
• Product Code: JWH
• UDI-Device Identifier: 00889024229242
• UDI-Public: (01)00889024229242(17)330708(10)65958311
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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 Catalogue Number: 42500606402
• Device Lot Number: 65958311
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female