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

Model Number N/A

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product is in process of being 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.

Event Description

It was reported that during the operation, the surgeon applied the biological femoral condyle implants and the cement platform implants, pressurised the prosthesis with a small 3mm gasket and tested the flexion and extension balance.After that, the oxford trial bearing w/slots was removed with a handle, and the oxford trial bearing w/slots was found to be broken when placed on the operating table.Delay of surgery: 20 minutes.

Event Description

It was reported that during the operation, the surgeon applied the biological femoral condyle implants and the cement platform implants, pressurised the prosthesis with a small 3mm gasket and tested the flexion and extension balance.After that, the oxford trial bearing w/slots was removed with a handle, and the oxford trial bearing w/slots was found to be broken when placed on the operating table.Delay of surgery: 20 minutes.

Manufacturer Narrative

(b)(4).G3: report source, foreign - event occurred in china.-the event reports that the instrument has fractured.This event occurred during surgery.This event resulted in a non-clinically significant extension to surgery time (20 mins).-the complaint has been confirmed following review of the returned instrument, which confirmed the instrument is fractured.Visual examination confirms the instrument has two fractures which are symmetrical and in the area where the tibial bearing inserter/extractor slots in.-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 7 similar complaints for the same item number.-a complaint history review identified 0 similar complaints for the same lot number.-the severity of the reported event is in line with this risk file.The occurrence rate for all similar events reported in the last three years is also in line with the risk file.The rpn is between low risk.- 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 reusable instrument lifespan manual instructs to look for fractures and surface damage during reprocessing.- the likely condition of the device when it left zimmer biomet is conforming to specification.-the likely root cause of the reported event could not be established.The slot serves as an attachment site for the tibial bearing inserter/extractor.The fractures on each side look symmetrical to each other suggesting an excessive force of equal load has been applied.-no corrective action required at this time.Both the severity and occurrence of the reported event are in line with the risk file.No harm beyond extension to surgery time, minor, has been reported.The item was distributed conforming.No root cause has been identified.Risk assessment: -this event occurred during surgery and resulted in a non-clinically significant delay to surgery time (20 mins).-this gives a severity score of 2.-the actual severity score is in line with the risk file.Occurrence assessment: a) sales data scope, -date: july 2017 to jun 2020 (most up to date sales data).-item numbers: all implants compatible with instrument all oxford trial bearings (see sales report for list of item numbers).B) number of items sold -292,987 c) complaint history search criteria: -date: 01 july 2017 to aug 2020 (date search was conducted) -item number ¿ all oxford trial bearings (see complaints search for list) -filters ¿ all complaint categories relating to damage or fractured instrument.D) number of complaints identified: -26 in total.E) occurrence ratio: -26:292,987 = 1:11,269, -this gives a severity score of 2.-the relevant line in the risk file includes a minimum occurrence score of 2, therefore, this is in line with the risk file.Risk score: - s2 x o2 ¿ rpn 4 (low).Corrective and preventive actions: no corrective action required at this time.Both the severity and occurrence of the reported event are in line with the risk file.No harm beyond extension to surgery time, minor, has been reported.The item was distributed conforming.No root cause has been identified.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 TRL BRG W/SLOTS SML 3MM
• Type of Device: KNEE TIBIA TRIAL PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10263456
• MDR Text Key: 201580319
• Report Number: 3002806535-2020-00320
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279346608
• UDI-Public: 05019279346608
• 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
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 32-422698
• Device Lot Number: ZB6660102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 66