MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FM HD 036/0MM 12/14 M 12/14; CERAMIC FEMORAL HEAD PROSTHESIS

Catalog Number 650-0837

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The customer reports that they wanted to implant the product mentioned below but it was not sterile : the external box was good, the plastic packaging too but the last pouch showed a hole.Usually the product is vacuum packed but this one was not due to the hole.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Investigation has determined that the reported event is a manufacturing issue and cross site investigation was carried out based on photographic evidence.Summary investigation: the manufacturing order related to involved product , lot number has been reviewed and do not show any non-conformity, rejection or concession.All the lot was accepted at the time of manufacturing.Complaint history review indicates that no additional complaint has been found which involved the affected part/lot combination.Moreover, no additional complaints have been found related to the issue description.According to gv2.24 rev.10 acondicionado de producto esteril: (packaging of sterile product), the sterile barrier is constituted by the blyster and lid, therefore the potential effect of failure sterile barrier could be compromised reported in the complaint description could not be evidenced.Although root cause has not been identified with the available information, no evidence have been identified that related the communicated event to the raw material, manufacturing or inspection of the involved part.Therefore, no corrective action or preventive action have been arisen due to the event.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 a hip replacement procedure, upon opening the packaging it was discovered that the second sterile barrier was compromised.Another product was used.No patient injury was reported.No delay of the surgery reported.

• Brand Name: DELTA CER FM HD 036/0MM 12/14 M 12/14
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7966656
• MDR Text Key: 123941847
• Report Number: 3002806535-2018-01144
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 650-0837
• Device Lot Number: 2018061298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1