MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET HIP SYSTEM 36MM COCR MOD HD +9MM; PROTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 05/03/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat#: 16-104156, lot#: 645350 rnglc+ ltd hole fin shl sz56.Cat#: 103533, lot#: 900690 ti low profile screw 6.5x30mm.Cat#: 51-104150, lot#: 6320163 tprlc 133 t1 pps ho 15x150mm.Cat#: xl-105894, lot#: 544650 arcomxl rlc 10deg 36mm sz24.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00958.

Event Description

It was reported that approximately 5 years post implantation of a right total hip arthroplasty, the patient was revised due to, fluid accumulation in the joint, and elevated metal ion levels.During surgery, metallosis was confirmed and determined to be related to the trunnion head interface.The head was removed, and the trunnion was noted to be a very short trunnion with a +9mm head high offset stem, which the surgeon believed predisposed the patient to metallosis.Metallosis was noted around the trunnion with black material on the inside of the head and the trunnion itself.All components were exchanged with competitor product without complications.No additional information was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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

Additional information received that approximately 5 months prior to the patient¿s revision, 20ml was aspirated from the right greater trochanteric area due to pain.Numbing medication was injected without steroids.The pain was minimally resolved with injection; however, the pain returned.The patient remained on chronic prednisone therapy.A second injection was planned prior to the revision.No additional information available.

• Brand Name: BIOMET HIP SYSTEM 36MM COCR MOD HD +9MM
• 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: 19047130
• MDR Text Key: 339433161
• Report Number: 0001825034-2024-00959
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304210554
• UDI-Public: (01)00880304210554(17)281119(10)328680
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032396
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• 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: 11-363665
• Device Lot Number: 328680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2018
• 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: Male
• Patient Weight: 98 KG