MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 19X190MM SPL TPR DIST; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Cat# 163663 28mm dia cocr mod hd +3mm nk lot#506730-1.Cat#11-301310 arcos con sz a hi 50mm lot#906280.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 - 2020 - 03607.

Event Description

It was reported a patient underwent a hip arthroplasty.Subsequently, the patient was revised approximately eight years post-implantation due to implant fracture.There was no reported trauma that could have contributed to the fracture.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The stem, cone body and head were returned for evaluation.The stem is not fractured, however the cone body and stem screw are fractured.Fracture analysis was performed on the cone body and stem screw.The fracture surface of the stem screw shows fracture surface artifacts including beach marks and ratchet marks, which are consistent with the fatigue failure mode.The mating fracture surface shows significant damage/smearing and is retained inside the stem.Side views of the screw threads shows evidence of thread shearing and pitting corrosion.A handheld xrf analysis of the screw could not be performed as no region of the returned device is large enough to completely cover the analyzer¿s aperture.The smooth fracture surface of the cone body is consistent with the fatigue failure mode; however no beach marks are visible at optical magnification to confirm.The fracture appears to have initiated on the lateral side and culminated in bending overload on the proximal side of the device.Xrf analysis found the cone body material to be consistent with ti6-4 titanium alloy.Operative notes were not provided; an xray was provided and reviewed by a healthcare professional.A right hip arthroplasty is present and the femoral implant is fractured at the neck with marked varus alignment of the implant at the fracture site.No definite osseous fracture is seen.Extensive lucency surrounds the proximal femoral implant, which appears loose.The implant fracture may in part be related to loosening of the femoral implant proximally with a toggling phenomenon.Eccentric femoral head position is secondary to mild liner wear.Patient anatomy is unremarkable apart from marked osteopenia.Device history record (dhr) was reviewed and no discrepancies were found.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.

• Brand Name: ARCOS 19X190MM SPL TPR DIST
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10587068
• MDR Text Key: 208552416
• Report Number: 0001825034-2020-03608
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 11-300919
• Device Lot Number: 273510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR