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

Catalog Number 42500606402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical product: articular surface fixed bearing constrained posterior stabilized (cps) right 10 mm height: catalog#42522600910, lot#65106817; tibia cemented 5 degree stemmed right size g: catalog#42532007902, lot#65890318; stem extension tapered cemented 14 mm diameter +30 mm length: catalog#42557000114, lot#65920781; all poly patella cemented 35 mm diameter: catalog#42540000035, lot#65800922; refobacin plus bone cem 2x20-3: catalog#3021180001-3, lot#x02aai0606.G2: foreign: germany.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial total knee arthroplasty without reported complication.Subsequently, the patient began to experience increasing pain.Twelve (12) weeks post-implantation, the patient had diagnostic x-ray images which revealed a perioprosthetic bone fracture of the distal femur.No trauma or intervention to correct the fracture has been reported.Due diligence is in progress for this event; to date no further information is reported.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.The product remains implanted.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records and x-rays were provided and reviewed by a health care professional.Review of the available records identified: femur fracture, pain unable to bear weight, patient using a wheelchair, moderate effusion, adequate healing, no instability, no sign of thrombus, severe vitamin d deficency, patient casted for fracture, varus positioning of the tibial component, osteopenia with eventual periprosthetic fracture of the distal femoral metaphysis, osteopenia and tibial component varus positioning could have led to femoral bone fracture.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial total knee arthroplasty without reported complication.Subsequently, the patient began to experience increasing pain with an inability to bear weight or fully flex the knee.Eighteen (18) days post-implantation, diagnostic images revealed dorsal medial supracondylar distal femur fractures.A cast was applied and conservative treatment was carried out.Due diligence is complete as multiple attempts have been made; all available information has been reported.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 8
• Type of Device: 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: 18365910
• MDR Text Key: 331008442
• Report Number: 3007963827-2023-00349
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024229242
• UDI-Public: (01)00889024229242(17)330320(10)65672299
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 42500606402
• Device Lot Number: 65672299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/18/2023; 03/20/2024
• Supplement Dates FDA Received: 02/12/2024; 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female