MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ARCOS CALCAR PROXIMAL BODY; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: unknown month and day in 2016.Report source: foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2021-02760.

Event Description

It was reported that the patient underwent a revision procedure approximately 5 years post implantation due to implant fracture.There was no specific incident that caused the fracture on the trunnion taper junction of the implant.The patient was walking and then all of a sudden his hip just gave way.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

The event was confirmed with radiographs received.Review of the available records identified the following: fracture of the femoral component of the hardware (at the tried union taper junction of the implant).Slight inferomedial eccentric positioning of the femoral head component.Periprosthetic lucencies surrounding the subtrochanteric femoral component as well as bone resorption, suggesting loosening/infection.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to 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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: d9, d10, g3, g6, h2.D10: 166066 arcos distal screw ti 5x30mm m 3709228, 166067 arcos distal screw ti 5x35mm m 3655500.

Event Description

No additional event information to report at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6.Proposed component code: mechanical g04-stem.One unknown ceramic head, stem, and taper were returned and evaluated.Upon visual inspection the stem has fractured inside of the taper with part of the stem remaining inside of the taper.There is also wear to the porous of the stem.The taper has fractured at the junction location with there being some scuffing to the head of the taper.The ceramic head is stuck on the taper with scuffing to the od.Arcos calcar proximal body was submitted for fracture surface analysis.Testing was conducted utilizing a keyence vhx-2000 digital microscope and jeol 6610 lv sem.While there is significant smearing on the fracture surfaces, faint beach marks are visible and suspected crack initiation region was identified.Excessive smearing obscured the micro artifacts on the fracture surface and the presence of faint beach marks suggests fatigue mode of failure.Complaint history review cannot be performed without product identification.A definitive root cause could not be determined.Event confirmed via returned product.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.

• Brand Name: UNKNOWN ARCOS CALCAR PROXIMAL BODY
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12543718
• MDR Text Key: 273694798
• Report Number: 0001825034-2021-02758
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: CAT#: 00223200118 CABLE LOT#: NI; CAT#: 00223200118 CABLE LOT#: NI; SEE H10 NARRATIVE; UNKNOWN ARCOS DISTAL STEM; UNKNOWN DISTAL SCREW; UNKNOWN DISTAL SCREW; CAT#: 00223200118 CABLE LOT#: NI; CAT#: 00223200118 CABLE LOT#: NI; UNKNOWN ARCOS DISTAL STEM; UNKNOWN DISTAL SCREW; UNKNOWN DISTAL SCREW
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male