MAUDE Adverse Event Report: BIOMET UK LTD. TNBN VG SSK360/DA360 LH FEM 60

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

On the vanguard 360 tinbn femur a distal hole is uncoated by tinbn.The femur was implanted regularly by applying bone cement on its inner surface.

Manufacturer Narrative

(b)(4).The follow up report is being submitted to relay additional information.Reported event was confirmed by visual inspection of picture of device.Device history record (dhr) was reviewed and no discrepancies were found.A review of the complaints data base has found one similar reported event for this vanguard tnbn item.A review of the drawing confirms that "one tapped hole will not be coated to allow product to be held during coating process".A review of the visual work instruction, for final inspection also confirms that "one of the threaded holes will not be covered".Investigation is complete and confirms that the product was manufactured to predefined specifications.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: TNBN VG SSK360/DA360 LH FEM 60
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7536586
• MDR Text Key: 108999690
• Report Number: 3002806535-2018-00856
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 185282TNBN
• Device Lot Number: 3758691
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1