MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD -3MM NK; PROTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Hair Loss (1877); Hearing Impairment (1881); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Visual Disturbances (2140); Dizziness (2194); Metal Related Pathology (4530)

Event Date 01/31/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat# rd118850, lot# 881660, m2a 38mmx50mm cup.Cat# 103202, lot 999940, taperloc por fmrl 7.5x135.Product will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00256 and 0001825034-2024-00259.

Event Description

It was reported that approximately 20 years post implantation of a left total hip arthroplasty, the patient was revised due to pain, systemic metal related pathology symptoms, and localized metallosis.The patient reportedly had elevated cobalt and chromium levels attributing to lightheadedness, dizziness, loss of balance, tinnitus, visual changes, hearing changes, memory loss, brittle nails and teeth, and hair loss.During the revision, trunnion corrosion was identified.The femoral head was replaced with a dual mobility construct without complications, and the initial cup and stem were retained.No additional information.

• Brand Name: M2A 38MM MOD HD -3MM NK
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18677074
• MDR Text Key: 335020915
• Report Number: 0001825034-2024-00260
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11-173661
• Device Lot Number: 000350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female