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 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

Cmp-(b)(4).Report source, foreign - event occurred in (b)(6).The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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.

Event Description

It has been reported that, during the surgery, the polymer was leaking from the inner pouch because part of the inner polymer pouch was unsealed.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.Four pictures were received and the reported event has been confirmed.In addition, the involved product was returned and analyzed: the inner cement pouch sealing was opened and damaged.Thus, the reported event has been confirmed.A sealing force test has been performed on a product received from a similar complaint ((b)(4) - same item reference and lot number) and showed that the pouch sealing force a was compliant with zimmer biomet valence specification.A complaint extract was done regarding packaging : inner pouch_open sealing: 4 complaints (involving 4 products), this one included, have been recorded regarding the brand cement pack (e) (sp) bbcr to date (b)(6) 2021, and since ever.2 complaints (involving 2 products), this one included, have been recorded on biomet bone cement r 1x40 jp, reference (b)(4), batch z35aaf1509, since ever.To date, no root cause could be determined for the reported packaging issue, however as a trend was identified, a global investigation has been initiated in order 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 part of the inner polymer pouch was unsealed.No adverse event has been 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
• MDR Report Key: 11723299
• MDR Text Key: 257398799
• Report Number: 3006946279-2021-00067
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• 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: Z35AAF1509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1