MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Inflammation (1932); Pain (1994); Synovitis (2094); Subluxation (4525)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: item number: unknown; lot #: unknown; item name: unknown oxford tibial component, item number: unknown; lot #: unknown; item name: unknown oxford femoral component.G2- switzerland.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a patient had an initial left medial unicondylar knee arthroplasty.Subsequently, the patient experienced a distortion trauma in which they sprained the left knee in a weight-bearing rotational movement.The patient underwent revision of the poly bearing due to unresolved pain in the knee.During the revision, the bearing was found luxated and fractured within the joint.Synovitis was also identified and removed.A new bearing was implanted without complications.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

This report is being submitted to correct the g3 in the previous medwatch report (3002806535-2023-00440).Correct g3: nov 25, 2023.

Event Description

This report is being submitted to correct g3 in the previous medwatch report (3002806535-2023-00440).Correct g3: nov 25, 2023.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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 and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.A review of the raw material certificate confirmed no abnormalities or deviations that could be related to the reported event.Medical records were provided and reviewed by a health care professional.The review identified a distortion trauma as contributing factor of the event: forced loaded flexion and rotation movement (weight-bearing maneuver up a staircase) - when turning, patient suffered a sprained trauma in his left knee, which resulted in a bang and he was no longer able to move his left knee properly.With the available information, a definitive root cause could not be determined.However, it is not excluded that the distortion trauma had an impact on the bearing fracture.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 available at the time of this report.

• Brand Name: OXF ANAT BRG LT MD SIZE 3 PMA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• 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: 18353920
• MDR Text Key: 330865012
• Report Number: 3002806535-2023-00440
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785933
• UDI-Public: (01)05019279785933(17)150927(10)2185099
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/27/2015
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 2185099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2010
• 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; Hospitalization
• Patient Sex: Male