MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK MAGNUM CUP SIZE 56; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Unequal Limb Length (4534)

Event Date 07/13/2023

Event Type  Injury  

Event Description

It was reported that approximately fourteen years post-implantation, the patient underwent a revision due to pain.During the revision, the surgeon encountered a significant amount of pseudotumor from metallosis and osteolysis of the femur and acetabulum.The acetabular and femoral components were found well-fixed.Only the head was revised.The procedure was completed without complications.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2014 - 01855 - 2 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.Complaint confirmed based on the provided medical records.Product identification was not provided therefore review of manufacturing and complaint history was not performed.Medical records identified the following: significant amount of pseudotumor encountered- debrided.Severe osteolysis of the proximal femur- stem found to be well fixed.Osteolysis around periphery of cup, tissue consistent with pseudotumor, cup well fixed, no significant damage to the bearing surface.Intra-op findings: pseudotumor, metallosis, intact femur and trunnion.The additional information does not change the outcome of the previous investigation.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: UNK MAGNUM CUP SIZE 56
• 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: 18649671
• MDR Text Key: 334633721
• Report Number: 0001825034-2024-00315
• Device Sequence Number: 1
• Product Code: JDI
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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
• Date Manufacturer Received: 04/05/2024
• 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: 104 KG