MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. NEXGEN OPTION CEMENTED FEMORAL COMPONENT SIZE D RIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	07/23/2017
Type of Reportable Event	Serious Injury
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.H6 - component code - proposed code is mechanical femur (g04) medical records provided confirmed the patient experienced a stress fracture of the distal femur above the knee arthroplasty and a pin was placed to ensure proper bone healing.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
No further event information available at the time of this report.
Event or Problem Description
It was reported that the patient underwent a right knee pin placement six (6) days following right knee arthroplasty due to a femoral periprosthetic fracture and pain.No additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen articular surface catalog #: 00596403012 lot #: 63631119, nexgen tibial tray catalog #: 00598603701 lot #: 63535337, nexgen patella catalog #: 00597206532 lot #: 63409706, heraeus medical palacos r + g bone cement catalog #: 66017569 lot #: 85964608 g2 - report source - foreign: event occurred in the united kingdom the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device 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 submitted to relay additional information.The following sections were updated: b4, b6, b7, g3, g6, h2, h3, h6, h11.Additional medical records were provided and reviewed.Based on the additional information received, it was identified that the patient's comorbidities (history of osteogenesis imperfecta, osteoporosis, rheumatoid arthritis and brittle bones) and the twisting motion put the patient at an increased risk for periprosthetic fracture.Although the root cause remains unchanged, zimmer biomet does not consider this to be a reportable event, as it can be reasonably deduced that the cause of the stress fracture was not related to the components or procedure.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
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: a4, a5, b4, b5, b6, b7, g3, g6, h2, h6, h11.
Event or Problem Description
It was reported that the patient underwent a right knee pin placement six (6) days following right knee arthroplasty due to a femoral periprosthetic fracture, pain and inability to stand.No additional information is available.

• Brand Name: NEXGEN OPTION CEMENTED FEMORAL COMPONENT SIZE D 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 ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20070428
• Report Number: 3007963827-2024-00321
• Device Sequence Number: 15577389
• Product Code: JWH
• UDI-Device Identifier: 00889024192249
• UDI-Public: (01)00889024192249(17)260430(10)63342343
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/04/2025

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 Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00576401452
• Device Lot Number: 63342343
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 11/22/2024; 03/19/2025; 07/15/2025
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 12/12/2024; 04/14/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White