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

Model Number N/A

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The product has being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.Concomitant medical products: oxford uni twin-peg femoral sm, catalog #: 166941, lot #: j6604484.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00917.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the paper peel-off lid is glued to the white foam.Subsequently, prosthesis was thrown in the foil on the ground during opening.

Event Description

It was reported that the paper peel-off lid is glued to the white foam and has thrown the prosthesis in the foil on the ground during opening.No harm to the patient or the user.No delay.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.D11: medical product: oxford uni twin-peg femoral sm, catalog #: 166941, lot #: j6604484.Multiple mdr reports were filed for this event, please see associated reports:3002806535-2019-00917-1.-the event reports that it was identified that that the top foam was adhered to the tyvek lid.This event occurred during surgery.No harm was reported.-the complaint has been confirmed following review of the returned packaging, which confirmed the foam has adhered to the tyvek lid.-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 9 similar complaints for the same item number.A complaint history review identified no similar complaints for the same lot numbers.The severity of the reported event and the calculated occurrence for all similar events in the last 3 years are in line with this risk file.The overall risk score is negligible.-these device(s) is/are used for treatment.-the reported event is not related to a combination of products; therefore, a compatibility review is not applicable.-the ifu provided with the device states to check the packaging for damage before use.-the likely condition of the device when it left zimmer biomet is non-conforming to specification.The correct packaging materials and sealing methods have been used.The likely cause of the reported event is not enough clearance between the top foam and the tyvek lid during the heat sealing process.This causes unintended heat transfers between the top foam and the tyvek lid, resulting in adhesion.The indent in the top foam (which have been caused by compression from the device) further indicate that the space within the blister would have been limited.-issue evaluation ie-11839 has been raised to further investigate this issue.Health hazard evaluation hhe-2020-00082 has been raised to assess the risk of product which may exhibit the issue in the field.Risk assessment: customer cannot deliver product into the sterile field in a controlled manor.The severity score associated with this failure mode is 2 (temporary or reversible impairment (without medical intervention)) with an occurrence score of 1 (<1 in 10000).Severity assessment: -this event occurred during surgery.No harm was reported.-this gives a severity score of 2.-the severity score is in line with the risk file.Occurrence assessment: a) sales data scope.-date: mar 2017 to feb 2020.-item numbers: all units with a packaging configuration that includes foams and a tyvek lid.B) number of items sold: (b)(4).C) complaint history search criteria: -date: 01 mar 2017 to 29 feb 2020.-complaint category ¿ packaging.-filters ¿ all complaint categories relating to packaging (not including label or debris) -keywords in complaint description ¿ stuck, stick, fell, ground, foam, shooting, paper, opening, lifted, malfunction, attached, adhered, urethane, foil, difficult, sterile.D) number of complaints identified: -67.E) occurrence ratio: (b)(4).Risk score: -s2 x o1 ¿ rpn 2 (negligible).Risk assessment summary: -the severity of the reported event and the calculated occurrence for all similar events in the last 3 years are in line with this risk file.The overall risk score is negligible.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: OXFORD UNI TWIN-PEG FEMORAL SM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9658739
• MDR Text Key: 198714210
• Report Number: 3002806535-2020-00061
• 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
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• 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: 166941
• Device Lot Number: J6565293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other