MAUDE Adverse Event Report: BIOMET UK LTD. M2A-MAGNUM MOD HD SZ 50MM; HIP PROSTHESIS

Catalog Number 157450

Device Problem Biocompatibility (2886)

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

Event Date 10/24/2019

Event Type  Injury  

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.

Manufacturer Narrative

(b)(4).D10 - associated medical devices: m2a-magnum recap cup 56odx50id; item# 157856; lot# 1488514 tprloc 12/14 por lat 11x142; item# 650-0264; lot# 1476477 magnum tpr adpr ti 42-50/+8mm; item# 130832; lot# 1338003 multiple mdr reports were filed for this event, please see the associated report: 3002806535-2023-00137.G2 - foreign: italy 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

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Medical records were provided and reviewed by a health care professional.The review identified the following.10 years post initial op; labs (third part medical records.Pdf pg.33) cobalt 75.77 (normal <1.0) chromium 37.86 (normal <1.0) 10 years and 5 months post initial op; consult (third part medical records.Pdf pg.31) the patient is examined for increase in metal ions in pta mom mri of the pelvis is required but left pta revision surgery is recommended 11 years and 1 month post initial op; revision (third part medical records.Pdf pg.1) left revision total arthroplasty metal on metal with necrosis no revision op report provided 1 days post revision; pathology report (third part medical records.Pdf pg.3) diagnosis: fragments of detrital synovitis, fragments of medullary bone with extensive intertrabecular infiltration by phagocytosing histiocytes, likely prosthetic material, fragments of detrital synovitis with the available information, a definitive root cause cannot be determined.Moving forward, if any further information is found which would change or alter any conclusions or information for this product, a supplemental report will be filed accordingly under mdr report number: 0001825034-2024-01143.Zimmer biomet will continue to monitor for trends.

• Brand Name: M2A-MAGNUM MOD HD SZ 50MM
• 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: 18797246
• MDR Text Key: 336438968
• Report Number: 3002806535-2024-00077
• Device Sequence Number: 1
• Product Code: MRA
• 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,Followup
• Report Date: 05/23/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 157450
• Device Lot Number: 1505536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2008
• 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): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 110 KG