MAUDE Adverse Event Report: BIOMET UK LTD. MALLORY-HEAD ACETABULAR SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the inner pouches were damaged upon receipt, prior to use.No patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Products have been returned to biomet (b)(4) for evaluation and forwarded to the complaints and vigilance engineer who has reported as follows: the devices have been visually examined which has concluded that damage to the implant pouch has occurred.This is likely due to the fins breaking through the pouch, and as a result, compromising the secondary sterile barrier.A risk assessment using product sales verses complaints has been completed and has confirmed the risk has not been exceeded and therefore there is no risk to patient safety.A new revised packaging configuration was introduced to update the packaging of the mallory shell devices.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaints data base found no complaints for damaged packaging recorded for the new packaging configuration.It can be concluded that the devices returned in this evaluation were conforming to pre-defined packaging specification at the time of manufacture.Zimmer biomet will continue to monitor for trends.

• Brand Name: MALLORY-HEAD ACETABULAR SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 6917139
• MDR Text Key: 89521178
• Report Number: 3002806535-2017-00916
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK030055
• 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: 01/11/2018

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 Model Number: N/A
• Device Catalogue Number: 104164
• Device Lot Number: R1784860A
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1