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

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This combined initial and final report is being submitted to relay additional information.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.(b)(6).Summary: coob confirmed following review of the photographs provided, which confirm the inner sterile barrier (pouch) is damaged.The event reports that the inner sterile packaging (pouch) is damaged.This event occurred during surgery.No further information has been provided.A review of the complaints database over the last 3 years has found no similar complaints for this item code.A review of the manufacturing history records confirms no abnormalities or deviations reported.This device falls within the scope of ca-03419, the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.A stock investigation will not be performed as the product was likely damaged during transit, therefore, a stock investigation is unlikely to yield any additional information.Risk assessment: this event occurred during surgery.No further harm was reported.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.Corrective and preventive actions taken: this device falls within the scope of ca-03419, the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.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 the outer packaging of the products is intact, the innermost layer of plastic packaging is damaged, and presents a non-vacuum form.Because the products is implanted in the patient, it cannot be returned.

• Brand Name: OXF UNI TIB TRAY SZ C RM PMA
• Type of Device: UNICONDYLAR KNEE 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: 10256396
• MDR Text Key: 203480174
• Report Number: 3002806535-2020-00311
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388899
• UDI-Public: 05019279388899
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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: 154723
• Device Lot Number: 6625120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2019
• 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
• Patient Age: 71 YR