MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK M2A MAGNUM 38 MM MOM; PROTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Inflammation (1932); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Tinnitus (2103); Balance Problems (4401); Muscle/Tendon Damage (4532); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 an initial hip arthroplasty.This has resulted in long medical care post-surgical to date.It is alleged the surgeon will not see the patient.Patient suffers from severe headaches, full body inflammation as in tendonitis in every tendon and major skin rashes.Patient is experiencing severe immune system issues which started immediately post implantation and ringing is ears.Patient is experiencing balance issues, memory issues, pain, and more systemically problems than before surgery.Patient has serum cobalt levels of 0.9, 0.7, 0.5, 0.5 and experiences fluctuation in activity levels.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow up report is being submitted to relay additional and/or corrected information.No product was returned; visual and dimensional evaluations could not be performed.Complaint not confirmed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information to report at this time.

• Brand Name: UNK M2A MAGNUM 38 MM MOM
• 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: 16619049
• MDR Text Key: 312046803
• Report Number: 0001825034-2023-00645
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 06/09/2023

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 Model Number: N/A
• Device Catalogue Number: UNK M2A MAGNUM 38 MM MOM
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 06/15/2023
• 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): Other