MAUDE Adverse Event Report: BIOMET UK LTD. VANGUARD CR ILOK FEM-LT 65; VANGUARD CEMENTED CR FEMORALS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 11/03/2021

Event Type  Injury  

Event Description

It was reported, that: there was asymmetric polyethene wear known since 2019, revised in 2021.Categorization: sade ¿ probably related to device and procedure, not related to instrumentation.Patient involvement - revision surgery.The patient is severely overweight (adipositas premagna) (bmi of 43.9) and was operated off-label.

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The client has indicated that the product will not be returned to zimmer biomet for an investigation.Concomitant medical products: medical product: tnbn pol cocr fin tib tray 71.Catalogue number: 141253tnbn.Lot number: unknown.Medical product: 10mm x 71/75mm cr.Catalogue number: unknown.Lot number: unknown.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: concomitant medical products: tnbn pol cocr fin tib tray 71: catalogue#141253tnbn, lot#2011101; vngd cr tib brg 10x71/75: catalogue#183440, lot#276160; optipac 40 refobacin bn cmt r: catalogue#4710500394, lot#101eab0703.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.D10 - medical devices: tnbn pol cocr fin tib tray 71; item# 141253tnbn; lot# 2011101.Vngd cr tib brg 10x71/75; item# 183440; lot# 276160.Optipac 40 refobacin bn cmt r nt r; item 4710500394; lot# 101eab0703.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

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.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records and radiographs were provided.Review of the available records identified the following: initial anatomic alignment of the left knee arthroplasty with subsequent tibial implant osteolysis, medial compartment metal on metal contact and medial tibial implant subsidence, and varus alignment as noted.Subsequent knee arthroplasty revision with anatomic alignment.Over time, there is evidence of tibial implant osteolysis with medial subsidence and medial polyethylene wear with metal on metal contact and knee varus.Femoral implant fit appears maintained.Bone quality is mildly osteopenic on all imaging.There is suspected tibial implant loosening with subsidence and medial compartment polyethylene wear as noted with resulting varus malalignment.The only contributing factor identified is the mild osteopenia.The listed patient weight of 297 pounds could contribute to early medial compartment failure.Patient anatomy is otherwise unremarkable.A definitive root cause cannot be determined.The x-ray review confirms that the femoral component fit appears maintained, however the patient weight of 297 pounds could contribute to early medial compartment failure.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.H3 other text : discarded.

Event Description

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

• Brand Name: VANGUARD CR ILOK FEM-LT 65
• Type of Device: VANGUARD CEMENTED CR FEMORALS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13797944
• MDR Text Key: 287429878
• Report Number: 3002806535-2022-00106
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00887868355462
• UDI-Public: (01)00887868355462(17)211027(10)2488367
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2021
• Device Model Number: N/A
• Device Catalogue Number: 183028TNBN
• Device Lot Number: 2488367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/03/2016
• 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: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.; SEEH10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 135 KG