MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN PEG CMNTLS FMRL MD; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is a combined initial and final report.Surgeon did not approve for return.Product has not been returned.However, complaint has been confirmed following review of the photographs provided.-the event reports that the inner sterile packaging (pouch) is damaged.This event occurred during surgery and resulted a clinically significant extension to surgery time (>30mins) was reported while another implant was located (actual delay was 45 mins).-the complaint has been confirmed following review of the photographs provided, which confirmed the inner sterile packaging (pouch) is damaged.-white debris can be seen on the implant which is likely from the foam packaging, indicating that the foam may also be abraded.-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 similar complaints for the same item number.-a complaint history review identified no similar complaints for the same lot number.-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.- 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 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 conforming to specification.The correct packaging materials and procedures have been used during the packaging process.The likely cause of the reported event is transit damage.- since the manufacture of this lot, the packaging configuration has been improved to use a stronger pouch material (nylon).Risk assessment: relevant line: - the line which relates to this event is line 1.2.1 package damage due to distribution.Inner barrier is breached, outer is not.The severity score associated with this failure mode is 2 (temporary or reversible impairment (without medical intervention)) with an occurrence score of 3 (1 in 100 to 1 in 1000).Severity assessment: a) severity assessment -this event occurred during surgery.A clinically significant extension to surgery time (>30mins) was reported (actual delay was 45 mins while another implant was located).-this gives a severity score of 2.-the severity score is in line with the risk file.Occurrence assessment: sales data scope: -date: (b)(6) 2017 to (b)(6) 2020 (most up to date sales data).-item numbers: all units with a packaging configuration equivalent to the packaging configuration in the reported event.Number of items sold: -742,616 complaint history search criteria: -date: (b)(6) 2017 to (b)(6) 2020 (most up to date sales data).-complaint category ¿ packaging.-filters ¿ all complaint categories relating to packaging (not including label or debris).-keywords in complaint description ¿ damaged, crushed, hole.Number of complaints identified: -37.Occurrence ratio: -37: 742,616 = 1:20,07.-this gives an occurrence score of 1.Risk score: -s2 x o1 ¿ rpn 2 (negligible).Corrective and preventive actions taken: since the manufacture of this lot, the packaging configuration has been improved to use a stronger pouch material (nylon).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 upon completion of preparation of the knee anatomy for implantation, desired implants were opened.Outer packaging all appeared intact but upon opening of oxford x-large femoral implant it was noticed that the innermost plastic packaging was severly compromised and the implant had retained wear and debris.At this time the implant was removed from sterile field and a replacement implant was sourced and used which caused a 45 minute delay.

• Brand Name: OXF TWIN PEG CMNTLS FMRL MD
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• 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: 10136895
• MDR Text Key: 195926436
• Report Number: 3002806535-2020-00285
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438266
• UDI-Public: 05019279438266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2021
• Device Model Number: N/A
• Device Catalogue Number: 161471
• Device Lot Number: 2225417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2011
• 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