MAUDE Adverse Event Report: BIOMET UK LTD. OXF HIGH FLEX FEM TRIAL MED; KNEE INSTRUMENT

Catalog Number 32-421432

Device Problem Off-Label Use (1494)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2-foreign- united kingdom.D10.Item#:32-423536 ;lot#:unknown ;itemname: oxf mp femur med metal tray ; item#:unknown ;lot#:unknown ;itemname: unknown oxford femur implant; investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

The patient was implanted with trail implant by accident, later patient was revised to implant definitive implant.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Device is used for treatment.Medical records were not provided.The root cause of the reported issue is attributed to use error.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: OXF HIGH FLEX FEM TRIAL MED
• Type of Device: KNEE INSTRUMENT
• 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: 18259028
• MDR Text Key: 329675035
• Report Number: 3002806535-2023-00411
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279042388
• UDI-Public: (01)05019279042388
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• 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
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32-421432
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose