MAUDE Adverse Event Report: BIOMET UK LTD. TINBN VG INT PS ANAT FM L 55MM

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Code Available (3191)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 patient under went a left knee replacement surgery.Subsequently, it was found during the procedure that the sterile packaging of the femoral component was damaged.Due to the sterility of the device being compromised the surgeon decided to use size 57,5mm femoral component instead of the planned 55mm.

Event Description

It was reported that the patient under went a left knee replacement surgery.Subsequently, it was found during the procedure that the sterile packaging of the femoral component was damaged.Due to the sterility of the device being compromised the surgeon decided to use size 57,5mm femoral component instead of the planned 55mm.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, g4, g7, h1, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Visual inspection confirmed the reported event.The product left manufacturing site conforming to specifications according to the mhr review.The root cause of the reported event is likely to be transit damage.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: TINBN VG INT PS ANAT FM L 55MM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7662156
• MDR Text Key: 113630620
• Report Number: 3002806535-2018-00931
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 183120TNBN
• Device Lot Number: 2595306
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1