MAUDE Adverse Event Report: . BIOMET BONE CMENT R 1X40; BONE CEMENT

Catalog Number 110035372

Device Problem Unsealed Device Packaging (1444)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6) 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

The polymer was leaking from the inner pouch because part of the inner polymer pouch was unsealed.No adverse health consequence has been reported as the result of this malfunction.

Event Description

The polymer was leaking from the inner pouch because part of the inner polymer pouch was unsealed.No adverse health consequence has been reported as the result of this malfunction.

Manufacturer Narrative

(b)(4).Several product pictures have been received and allowed to confirmed the reference and the batch of the product involved through the labels.Moreover, pictures show that the inner cement pouch sealing is opened on the right side and seems to be open on two bottom corners, which confirms the reported event.The product was returned and lab analysis was performed.The product analysis shows that the returned product is one cement pack.The received product comprises the outer box, the inner cement pouch, the monomer pouch in its outer pouch and the labels.The inner cement pouch sealing is opened at the top of the pouch and damaged at both corners of the pouch¿s bottom.A sealing force test has been performed and showed that the pouch sealing force a was compliant with zimmer biomet valence specification.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding inner cement pouch open sealing: 9 complaints (9 products), this one included, have been recorded on cement pack soft pouch since ever and up to date ((b)(6) 2021).4 complaints (4 products), this one included, have been recorded on biomet bone cement r 1x40, reference (b)(4), batch z35aaf1509.Investigation results concluded that the reported event was due to a punctual packaging issue (sealing process).The investigation confirmed the reported event.An action has been initiated in order to deeper investigate the cause of the event with the cement pouch supplier and to consider to implement actions to avoid the recurrence of this type of issue.A summary of the investigation has been sent to the customer.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 CMENT R 1X40
• Type of Device: BONE CEMENT
• Manufacturer (Section D): .; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 11693900
• MDR Text Key: 257400152
• Report Number: 3006946279-2021-00064
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00887868358487
• UDI-Public: 0887868358487
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

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 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: 04/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1