MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Adhesion(s) (1695); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)

Event Date 07/14/2022

Event Type  Injury  

Event Description

It was reported the patient had increasing pain in the area of the right knee joint without remembering any trauma, approximately 5 years after implantation of one axis-guided knee prosthesis as part of a ktep.Further diagnostics show radiologically a shaft fracture of the femoral component at the transition femoral shield/prosthesis.In the immediate vicinity, smaller metal-dense structures that are clinically dem correspond to the broken cone of the femoral shield.The distal femoral component is loose.Bone shows a metaphyseal defect situation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Implant date: unknown day and month in 2017.Report source: (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient had increasing pain in the area of the right knee joint without remembering any trauma, approximately 5 years after implantation of one axis-guided knee prosthesis as part of a ktep.Further diagnostics show radiologically a shaft fracture of the femoral component at the transition femoral shield/prosthesis.In the immediate vicinity, smaller metal-dense structures that are clinically dem correspond to the broken cone of the femoral shield.The distal femoral component is loose.Bone shows a metaphyseal defect situation.Patient was revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported the patient had increasing pain in the area of the right knee joint without remembering any trauma, approximately 5 years after implantation of one axis-guided knee prosthesis as part of a ktep.Further diagnostics show radiologically a shaft fracture of the femoral component at the transition femoral shield/prosthesis.In the immediate vicinity, smaller metal-dense structures that are clinically dem correspond to the broken cone of the femoral shield.The distal femoral component is loose.Bone shows a metaphyseal defect situation.Patient was revised due to pain, instability, and implant fracture.During the revision it was noted there was extensive synovitis, altr, metallosis, loosening, bone loss, metal debris, and scar tissue.No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b5; d6; d10; g3; g6; h6.D10: ref (b)(4) lot 63070569 femur.Ref (b)(4) lot 62986541 femur augment.Ref (b)(4) lot 63463243 femur augment x 2.Ref (b)(4) lot 63249712 articulating surface.Ref (b)(4) lot 63138091 femur augment.Ref (b)(4) lot 63687929 stem extension.Ref (b)(4) lot 63601109 tibia, rotating hinge.Ref (b)(4) lot 63722781 stem extension.Competitor bone cement x 4.Competitor 14 mm plug x2.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 Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Suggested comp code- mechanical (04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the implant fractured, extensive synovitis with metallosis, rom flexion to 120, and instability, metal debris extends beyond the proximal femoral shaft, bone loss, femoral implant completely loose, and metal debris imbibed scar tissue in the interfacial tissue.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of being implanted scratched / bio-debris and the post feature has fractured.The femoral component was sent for fracture analysis.Results: striations are visible which suggest the fatigue failure mode.In several areas, possibly embedded spherical particles were observed.Root cause is unchanged.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 Description

No further event information available at the time of this report.

• Brand Name: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT
• Type of Device: 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: 15198202
• MDR Text Key: 297587148
• Report Number: 0001822565-2022-02344
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024199156
• UDI-Public: (01)00889024199156(17)200930(10)63070569
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00588001502
• Device Lot Number: 63070569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN ARTICULAR SURFACE.; UNKNOWN TIBIAL COMPONENT.
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 153 KG