MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRL BRG W/SLOTS MED 3MM MM; KNEE TIBIA TRIAL PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is available to be returned to zimmer biomet for investigation.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.

Event Description

It was reported that dr.(b)(6) was trialling with the bearing and when he tried to take it out of the patient with the bearing inserter, the bearing inserter broke into 2 pieces.No harm to patent.No delay of the procedure reported.

Event Description

It was reported that dr.(b)(6) was trialing with the bearing and when he tried to take it out of the patient with the bearing inserter, the bearing inserter broke into 2 pieces.No harm to patent.No delay of the procedure reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Due to circumstances surrounding the covid-19 pandemic, complaint product return cannot be performed at this time.Therefore, the complaint investigation will proceed with currently available information.Should the complaint product become available, the complaint investigation will be updated as appropriate.We have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 6 similar complaints reported with these items.Risk assessment: risk management documents the estimated residual risk associated with the reported event.The root cause of this complaint could not be determined with the information provided to date.Therefore, a line relating to a specific hazard could not be selected for assessment.The event reports the instrument fractured during surgery, but no further harm has been reported.Therefore, the severity is considered s-2 (minor) as per definitions within the severity table in the attached rmr, which is in line with the risk file.The outcome of this complaint 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 years prior to the notification date, being nov 2020.Since the instrument in question is reusable, number of uses is better represented by the sales of the compatible implants.Therefore, the sales for all compatible oxford knee system item has been obtained and used to calculate occurrence.Sales (jan 2017 to nov 2020) = (b)(4) units (see sales report for list of item numbers).Complaints search was conducted for events occurring between nov 2017 to nov 2020 for item 32-422703.6 complaints were identified for this item number including (b)(4).Therefore, the calculated occurrence rate is (b)(4).This is considered an acceptable occurrence rate as per the rmf which estimates an acceptable occurrence rate of 2:(b)(4).No corrective or preventive actions are deemed necessary at this time.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 dr.Page was trailing with the bearing and when he tried to take it out of the patient with the bearing inserter, the bearing inserter broke into 2 pieces.No harm to patent.No delay of the procedure reported.

Manufacturer Narrative

(b)(4) this final report is being submitted to relay additional information.Complaint summary: the complaint has been confirmed following review of the returned instrument, which confirmed the instrument has fractured around the slot.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A complaint history review identified 13 similar complaints (14 including initiating complaint) for the same item number.A complaint history review identified no similar complaints for the same item/lot combination.The risk associate with the reported event is addressed the cemented oxford partial knee system risk file.The severity of the reported event is in line with the risk file, and the occurrence rate of all similar events reported in the last 3 years is also in line with the risk file.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The likely condition of the device when it left zimmer biomet is conforming to specification.The instrument has been in the field for approximately 2 years so the fracture is most likely caused by repeated assembly and disassembly as well as repeated reprocessing (cleaning/sterilisation) cycles.The reusable instrument lifespan manual details that fracture is an indication that the instrument is worn to an extent that it is no longer suitable for use.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF TRL BRG W/SLOTS MED 3MM MM
• Type of Device: KNEE TIBIA TRIAL 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: 11010039
• MDR Text Key: 227265616
• Report Number: 3002806535-2020-00528
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422703
• Device Lot Number: Z19D1082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1