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

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); High metal ion levels (4847); Joint effusion (4849)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6.H6: component code: mechanical (g04) - head.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 related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right total hip arthroscopy was performed.Approximately four years later, an aspiration occurred due to pain.The results showed inflammation.The patient was then revised due to pain, elevated metal ions, and metallosis.Black material was noted on the inside of the head and trunnion, and the trunnion was no longer smooth.All products were explanted and replaced with competitor products.This complaint was confirmed based on the provided medical records; however, 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: BIOMET HIP SYSTEM 36MM COCR MOD HD +9MM
• Common Device Name: 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
• Report Number: 0001825034-2024-00959
• Device Sequence Number: 15574081
• Product Code: JDI
• UDI-Device Identifier: 00880304210554
• UDI-Public: (01)00880304210554(17)281119(10)328680
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K032396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/09/2024; 06/11/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/16/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 98 KG