MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. VANGUARD ROCC POR FEM S62.5 R; KNEE PROSTHESIS

Catalog Number P09VMD04

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2 - foreign: japan.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that when the package was opened during surgery, the sterile package of a femoral knee implant was damaged.As a result, the operation was completed with a backup product.This event is related to a malfunction that could potentially lead to a sterility issue.However, no patient harm or further outcome was reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Pictures have been provided and show the product sealed in its original packaging.The sticker on the product confirmed its identification.Some crease is visible on one side of the blister.Visual examination of the returned product showed cracks and damages on the outside of the blister pack.The area is fractured but not deformed and there is no evidence of impact marks.The inner packaging including bag and foam is present.The seal appears intact with a uniform blue color and the bag appears to be still under vacuum.The label has been manipulated to open the packaging.The blister pack is fractured from top to bottom on the side with a star-shaped split at the top of the blister.This could indicate that this damage could have been caused by an external shock.A review of the device manufacturing records confirmed no abnormalities or deviations.With the available information, a definitive root cause could not be determined.A communication has been sent to the validation packaging department.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: VANGUARD ROCC POR FEM S62.5 R
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18648804
• MDR Text Key: 334630411
• Report Number: 3006946279-2024-00007
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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 Catalogue Number: P09VMD04
• Device Lot Number: 0001713867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose