MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/+3MM; HIP ARTHROPLASTY

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign: event occurred in (b)(6).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

It was reported the there was sterile packaging issue of biolox ceramic head.No harm or delay to surgery.

Manufacturer Narrative

(b)(4).The returned product confirms the reported event.Complaint out-of-box (coob) has been confirmed.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 2 complaints reported with the item(including initiating complaint).Issue evaluation (b)(4) has previously been raised for a similar reported event, and resulted in a correction to change to the packaging configuration for the item number within this complaint.The thickness of the top foam has been changed, which in turn increases the gap between the top foam and tyvek lid, therefore reducing the probability that the top foam will adhere to the tyvek lid during the sealing process.This change was implemented following the manufacture of the lot number in this complaint.Health hazard evaluation (b)(4) was raised to assess the risk of the top fam adhering to the tyvek lid.This hhe resulted in a no field action recommendation.

Event Description

It was reported the there was sterile packaging issue of biolox ceramic head.No harm or delay to surgery.

• Brand Name: DELTA CERAMIC FEM HD 36/+3MM
• Type of Device: HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11730776
• MDR Text Key: 247507314
• Report Number: 3002806535-2021-00126
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K200959
• 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: 07/21/2021

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 Model Number: N/A
• Device Catalogue Number: 650-0662
• Device Lot Number: 2019100705
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1