MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign: event occurred in (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent revision surgery due to a fractured oxford uni-knee insert.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr 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.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

It was reported that a patient underwent revision surgery due to a fractured oxford uni-knee insert.

Manufacturer Narrative

(b)(4).This final/follow-up report is being submitted to relay additional information.G3: report source, foreign - event occurred in switzerland.D10: product has been returned to zimmer biomet for investigation the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a knee revision surgery due to implant fracture.Additional information: the product has been returned to zimmer biomet for investigation.

Event Description

It was reported that a patient underwent revision surgery due to a fractured oxford uni-knee insert.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in switzerland.A right oxford anatomic bearing was revised due to fracture after approximately 12 years and 7 months in vivo.The oxford bearing was received split in two fragments, thus confirming the reported cause of revision.The relevant manufacturing history records indicate that the parts were manufactured and sterilised in accordance with the applicable specifications.Visual examination and measurements of the fragments indicated extensive damage of the superior articulating surface of the bearing, with the thickness of the central region of the component being 2.65 mm below its nominal thickness.Further information such as patient information, radiographs and surgical notes are required to confirm the root cause of the component fracture.However, high wear due to third body debris and embrittlement due to induced oxidation likely contributed to the failure.The mhr review indicates that the product was most likely conforming to design specification when it left zimmer biomet control, and the likely failure mode is wear due to third body debris and embrittlement due to induced oxidation.Risk assessment: failure analysis report: a right oxford anatomic bearing was revised due to fracture after approximately 12 years and 7 months in use.The femoral and tibial components are presumed to have been left in vivo.The polyethylene bearing was received split in two fragments, both presenting extensive wear and material loss from the superior articulating surface.This was confirmed by measurements compared with the dimensions specified on the relevant engineering drawing.The root cause of the bearing wear and fracture could not be determined in this instance with the available information.However, high wear due to third body debris and embrittlement due to induced oxidation likely contributed to the failure.The reported event states revision surgery due to implant fracture.The severity score is 3, which is defined in the rmr as: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.Therefore, the reported event is considered to be within the severity of the rmr.In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 calendar years prior to notification date, being oct 2019.Sales (oct 2016 ¿ oct 2019 inclusive) = (b)(4) units.Complaints search was conducted for events occurring between oct 2016 ¿ oct 2019 for item 159569.Three complaints were identified for this item number including (b)(4).Therefore, the calculated occurrence rate is (b)(4) or (b)(4).This is considered an acceptable occurrence rate as per the rmf ((b)(4) is considered an occurrence score of 3 occasional:(b)(4) 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.

• Brand Name: OXF ANAT BRG RT SM SIZE 4 PMA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9278401
• MDR Text Key: 173066743
• Report Number: 3002806535-2019-00840
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 159569
• Device Lot Number: 1232980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 11/28/2019; 02/03/2020; 04/29/2020
• Supplement Dates FDA Received: 12/10/2019; 03/04/2020; 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention