MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK MALLORY-HEAD SIZE 13 FEMORAL COMPONENT; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Discomfort (2330); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00305 0001825034 - 2024 - 00306 0001825034 - 2024 - 00307 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.

Event Description

It was reported that approximately thirteen years post-implantation, the patient underwent a revision due to pain, swelling, stiffness, osteolysis, pseudotumor, and elevated metal ions.During the procedure, a large amount of metal stained fluid was seen.A moderate periarticular pseudotumor was debrided.The head was exchanged with a polyethylene articular surface without complications.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on the review of provided medical records.Part and lot identification are necessary for review of device history records, neither were provided.Medical records identified the following: failure secondary to metallosis.Posterior approach with a large metal stained fluid evacuated.Moderate periarticular pseudotumor debrided.Stem and cup well fixed and remained implanted.X-ray: no loosening or failure, noted osteolysis in greater trochanter with no progression.A definitive root cause cannot be determined.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.

• Brand Name: UNK MALLORY-HEAD SIZE 13 FEMORAL COMPONENT
• 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: 18662029
• MDR Text Key: 334797077
• Report Number: 0001825034-2024-00304
• Device Sequence Number: 1
• Product Code: LZO
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/03/2024
• 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: Male
• Patient Weight: 95 KG
• Patient Race: Black Or African American