MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE STRAIGHT IMPACT PLATE

Catalog Number 110028874

Device Problems Nonstandard Device (1420); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Concomitant medical products: avantage curved handle; item #: 110031337; lot #: 315950.Recall was performed on the affected item.This item was not delivered to the usa.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported that during a hip revision when the handle was hold in an oblique position it was not possible to unlock the handle.There was no impact on patient.

Event Description

It was reported that during a hip revision when the handle was hold in an oblique position it was not possible to unlock the handle.There was no impact on patient.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: e1, g1-2, g4, h2, h3, h6, h7, h10 h3 - the device evaluation was not performed as the product was not returned and the batch number was not communicated.H7 - recall was performed on the affected item.The manufacturing review was not performed as the batch number was not communicated.However, other similar products were returned to zimmer biomet.An analysis was performed by the r&d team on the products returned for the same event and the galling issue was confirmed.Investigation showed that the event was caused by the material of the avantage straight impact plate.A recall was performed on the affected item.Please note that the products in the scope of this recall were not delivered to the usa.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: AVANTAGE STRAIGHT IMPACT PLATE
• Type of Device: AVANTAGE STRAIGHT IMPACT PLATE
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8673152
• MDR Text Key: 147462508
• Report Number: 3006946279-2019-00292
• Device Sequence Number: 0
• Product Code: HRS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/17/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110028874
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 74 YR