MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. BIOMET BONE CEMENT R 1X40 JP

Catalog Number 110035372

Device Problem Unsealed Device Packaging (1444)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).No further information provided (x-rays, surgical report, photographs, lab test).The product analysis was not performed as the product was not returned to the manufacturer.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.A sealing force test has been performed on a product received from a similar complaint ((b)(4) - same item reference) and showed that the pouch sealing force a was compliant with zimmer biomet valence specification.A complaint extract was done regarding packaging : inner_cement_pouch_open_sealing: 12 complaints (involving 12 products), this one included, have been recorded on biomet bone cement r 1x40 jp, reference 110035372, from (b)(6) 2018 to (b)(6) 2021.8 complaints (involving 8 products), this one included, have been recorded on biomet bone cement r 1x40 jp, reference 110035372, batch z34eaf1509, since ever.Investigation results concluded that the reported event was due to manufacturing (sealing process).A scar ((b)(4)) has been initiated in order to deeper investigate the cause of the event with the cement pouch supplier osartis and to consider to implement actions to avoid the recurrence of this type of issue.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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, during the surgery, the polymer was leaking from the inner pouch because a part of the inner polymer pouch was unsealed.In addition, it was reported that the surgery was finished with backup product.No adverse event was reported as a result of the malfunction.

• Brand Name: BIOMET BONE CEMENT R 1X40 JP
• 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: 12238203
• MDR Text Key: 266008998
• Report Number: 3006946279-2021-00118
• Device Sequence Number: 1
• Product Code: LOD
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 110035372
• Device Lot Number: Z34EAF1509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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