MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. BIOMET BONE CEMENT R 40 -3

Catalog Number 3035890011-3

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).One picture has been received and the reported event was confirmed as it can be seen that the inner cement pouch sealing is damaged and that cement powder leaked outside the inner pouch.The product analysis can't be performed as the product was not returned.The complaint is related to a well-known event, previously evaluated and investigated.No further investigation is required as per 21 cfr part 820.198 complaint files §(b) and (c).Investigation results concluded that the reported event was due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.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 has been reported that, before the surgery, it was found (by zb staff) that the inner package had leaked.In addition it was reported that the product will not be returned due to the cost of shipment.No adverse event has been reported as a result of the malfunction.

Event Description

It has been reported that, before the surgery, it was found (by zb staff) that the inner package had leaked.In addition it was reported that the product will not be returned due to the cost of shipment.No adverse event has been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.This follow-up report is being submitted to relay corrected information.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.Complaint history identified no additional complaints for the reported part/lot combination.A definitive root cause cannot be determined.Further invetigation is being conducted through our capa process.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: BIOMET BONE CEMENT R 40 -3
• Type of Device: BONE CEMENT
• 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: 11517176
• MDR Text Key: 240781414
• Report Number: 3006946279-2021-00038
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 3035890011-3
• Device Lot Number: 826AAC0512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2018
• 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