MAUDE Adverse Event Report: BIOMET UK LTD. TAPERLOC 12/14 POR LAT 11X142; HIP PROSTHESIS

Catalog Number 650-0264

Device Problem Biocompatibility (2886)

Patient Problems Synovitis (2094); Metal Related Pathology (4530)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - associated medical devices: m2a-magnum recap cup 56odx50id; item# 157856; lot# 1488514.M2a-magnum mod hd sz 50mm; item# 157450; lot# 1505536.Magnum tpr adpr ti 42-50/+8mm; item# 130832; lot# 1338003.G2 - foreign: italy.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00137.3002806535-2024-00077.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent a revision surgery eleven years post initial implantation due to elevated metal ion levels and metallosis.Due diligence is in progress for this complaint; to date no further additional information or product has been received.

• Brand Name: TAPERLOC 12/14 POR LAT 11X142
• Type of Device: HIP PROSTHESIS
• 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: 18993238
• MDR Text Key: 338884917
• Report Number: 3002806535-2024-00118
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 05019279718993
• UDI-Public: (01)05019279718993(17)180228(10)1476477
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 650-0264
• Device Lot Number: 1476477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 110 KG