MAUDE Adverse Event Report: BIOMET UK LTD. VANG PS POR/HA FEM - RT 72.5 72.5; VANGUARD CEMENTLESS CR FEMORAL

Catalog Number 167074

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

After opening of the external packaging and the internal packaging, they noticed that the sterile packaging was pierced and could not ensure the product sterility.They took another product.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

After opening of the external packaging and the internal packaging, they noticed that the sterile packaging was pierced and could not ensure the product sterility.They took another product.

• Brand Name: VANG PS POR/HA FEM - RT 72.5 72.5
• Type of Device: VANGUARD CEMENTLESS CR FEMORAL
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8098932
• MDR Text Key: 128276293
• Report Number: 3002806535-2018-01212
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 167074
• Device Lot Number: 2780223
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/22/2018
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1