MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ F RM PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.The results of this investigation have confirmed that the existing polyamide pouches used as the secondary sterile barrier in the packaging is found to be less robust when subjected to above average handling and shipping.The current packaging configuration had originally successfully passed the acceptance criteria as part of the packaging validation.The product as it is packed at biomet conforms to packaging requirements.The complaints however are valid following abnormal handling and shipping.An ide study was completed in 2015 to re validated the oxford tibial tray packaging.Review of complaint history found no additional related issues for this item.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause was due to handling and transportation issue during distribution.There are warnings in the package insert that this type of event can occur and risks are addressed in ide validation risk documentation.The current risk to patients is very low as the packaging was conforming.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.(b)(4).

Event Description

It was reported that during an oxford knee procedure on (b)(6) 2015, the tibial tray sterile packaging was reported to be damaged.Another tibial tray was opened and the procedure was completed without delay.There was no patient contact with the product.The product was sent back.

• Brand Name: OXF UNI TIB TRAY SZ F RM PMA
• Type of Device: PROSTHESIS, KNEE
• 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: 6937707
• MDR Text Key: 89044918
• Report Number: 0001825034-2017-08330
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 154776
• Device Lot Number: 2756977
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2012
• 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