MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FM HD 036/0MM 12/14

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

During the total hip arthroplasty upon opening the implant packaging the tyvek lid appeared to stick to the top foam.This resulted in the implant coming out of the blister unexpectedly.A new implant was used to complete the procedure.

Manufacturer Narrative

(b)(4).Products have been returned to biomet spain for evaluation and forwarded to a regulatory compliance engineer for investigation.Summary of investigation: taken into account the following facts: the foam (ref.Jv540125; lot 4907120) and the tyvek (reference jv540073; lot 0000761004) of the returned product have been verified and matches with the ones indicated on the bill of material of the manufacturing order.The lidding material consists of a coated and an uncoated side.The coated lid surface contains glue on all its surface, this coated side is the part to contact the blister surface.According to the blister specifications, the effective sealing rim is 10mm.The sealing machine is a flat surface which applies heat on all the lid surface.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database has found no similar complaints reported with this item # / lot # combination.A trend has been identified regarding issues with the tyvek lid sticking to the top foam on various implants, which cause the implant to fall out of the blister pack when opened in surgery.As a result of this trend a hhed2015-028 was initiated.It can be seen from the photographs that the impressions left in the foam would likely result in the middle section of the top foam being in contact with the tyvek lid thus causing the adhesion to take place as described within the pce summary.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.

• Brand Name: DELTA CER FM HD 036/0MM 12/14
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7646541
• MDR Text Key: 112996931
• Report Number: 3002806535-2018-00919
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-0837
• Device Lot Number: 2018012046
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1