MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL MD; KNEE PROSTHESIS

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 10/11/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign ¿ canada.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 loosening of the femoral component occurred.A fractured anterior peg could have been a contributing factor.The patient was revised to a total knee.

Manufacturer Narrative

(b)(4).Visual examination of the provided pictures confirmed a broken peg.The quality of the photograph however is not of adequate quality to comment on the mode of fracture.The part of the peg that has broken off is embedded in what appears to be bone removed to accommodate the total knee femoral implanted at this revision surgery.The femoral component also has bone cement attached but only to half of the inner surface.Without being able to assess the physical product or the underside of the bone with the peg embedded in it, it is not possible to comment on cementing technique.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Medical records were not provided.A definitive root cause cannot be determined.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Product was returned and evaluated.Visual inspection of the returned item#: 166942, lot#: j3937399 found it to exhibit signs of being implanted scratched / nicked /foreign material on the distal surface one of the posts has fractured off.The diameter of the fractured post was verified as within specification.Sem analysis was performed which concluded that the fracture was due to fatigue.A definitive root cause cannot be determined.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: OXFORD UNI TWIN-PEG FEMORAL MD
• Type of Device: 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: 15742240
• MDR Text Key: 303141739
• Report Number: 3002806535-2022-00456
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868354854
• UDI-Public: (01)00887868354854(17)261121(10)J3937399
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010014
• 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
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 166942
• Device Lot Number: J3937399
• 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: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2016
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose