MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-38 CUP NON FLARED SZ 50MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Metal Related Pathology (4530)

Event Date 09/19/2022

Event Type  Injury  

Event Description

It was reported that approximately thirteen years post-implantation, the patient had a right hip revision due to elevated metal ion levels and concern for metal on metal wear.During the procedure, the patient had a good deal of serosanguineous fluid in the joint and metal pathology was noted.A new liner and head were placed.The stem and cup remained implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: cat# 11-103203 lot# 553970 taperloc por lat fmrl 9x137.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00530.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided; review of the available records identified the following: an initial right tha was performed.The patient developed elevated metal ions, and a revision was performed.Staining was found on the tissues and fluid found around the joint from a metal on metal reaction.Wear was noted.The head was explanted and replaced.A definitive root cause cannot be determined.This complaint was confirmed based on the provided medical records.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: M2A-38 CUP NON FLARED SZ 50MM
• Type of Device: PROSTHESIS, 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: 18787772
• MDR Text Key: 336320596
• Report Number: 0001825034-2024-00531
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

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: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 15-106050
• Device Lot Number: 922530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• 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): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 98 KG