MAUDE Adverse Event Report: BIOMET UK LTD. UNK BIOLOX DELTA MODULAR CERAMIC HEAD; HIP PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: unknown exceed abt acetabular shell; unknown ceramic insert; unknown liner; unknown stem.Report source: foreign: country: (b)(6).Customer has indicated that the product will not be 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 patient underwent a left hip revision procedure approximately 6 years post implantation as the patient began experiencing pain in the left hip and presented to physician 2 months before the revision where x-rays were taken and showed the liner had cracked and the head was wearing directly on the shell.The patient underwent a revision to replace the implant.During the surgery, significant metallosis was noted.The surgeon was unable to complete the surgery at that time and patient was brought back to the operating room approximately 1 month later to complete the surgery successfully.No additional information.

Manufacturer Narrative

(b)(4).The investigation determined that (b)(4) reporting the ceramic head is to be made not a complaint as it is secondary to the liner fracture.The event reporting the fractured liner ((b)(4)) will be reported by medwatch facility uk - 3002806535.

Event Description

It was reported the patient underwent a left hip revision procedure approximately 6 years post implantation as the patient began experiencing pain in the left hip and presented to physician 2 months before the revision where x-rays were taken and showed the liner had cracked and the head was wearing directly on the shell.The patient underwent a revision to replace the implant.During the surgery, significant metallosis was noted.The surgeon was unable to complete the surgery at that time and patient was brought back to the operating room approximately 1 month later to complete the surgery successfully.No additional information.

• Brand Name: UNK BIOLOX DELTA MODULAR CERAMIC HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12082324
• MDR Text Key: 258889663
• Report Number: 3002806535-2021-00275
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK BIOLOX DELTA CERAMIC HEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention