MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. VANGUARD ROCC POR FEM S60 L; KNEE PROSTHESIS

Model Number N/A

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

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported that when the package was opened prior the 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).G2: foreign: japan.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of both provided pictures and returned product identified an implant blister damaged on one corner.Indeed, there are cracks on the plastic.No signs of damage to the box to cause the broken blister has been found.Pictures have been provided to the packaging department, hereafter their analysis: the blister pack appears to have suffered a shock: one area is fractured but not deformed.The packing carton does appear to be intact, only the blister pack is affected.The seal does not appear to be damaged, and the foams are still present.It seems unlikely that the shock was caused by an external impact during transport, in the original box.Insofar as the foams are present, the risk of the packaged part moving and causing the shock is low.The defect is probably the result of a direct impact on the blister pack (fall, contact with a sharp object, etc.).A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.With the available information, a definitive root cause could not be determined.

Event Description

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

• Brand Name: VANGUARD ROCC POR FEM S60 L
• 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: 19094576
• MDR Text Key: 340112948
• Report Number: 3006946279-2024-00019
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03599870105344
• UDI-Public: (01)03599870105344(17)270702(10)0001663748
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/24/2024

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 Model Number: N/A
• Device Catalogue Number: P09VMG03
• Device Lot Number: 0001663748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• 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