MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X150MM SPL TPR DIST; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 36mm cocr mod hd -6mm cat# 11-363660 lot# 035250.Arcos con sz a hi 50mm cat# 11-301310 lot# 514810.Foreign report source: (b)(6).Visual inspection confirmed the stem to have fractured.The stem screw and fractured tip remain assembled with the cone body.The shaft of the stem is heavily gouged and deformed.The returned device was reviewed with visual examination and optical microscopy using a keyence vhx-1000 digital microscope.The side view of the stem shows post-fracture damage consistent with extraction as well as light colored deposits.The fracture surface also shows some post-fracture damage.Beach marks, consistent with the fatigue failure mode, can be observed across the middle of the fracture surface and radiate from the likely fracture initiation site.Possible evidence of fretting is visible.Conclusion: fracture surface artifacts suggest the fatigue failure mode culminating in overload fracture.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right femur sub-trochanteric fracture repaired with arcos stem and 4 unk cables.Subsequently implant fracture occurred post fall to ground, revision later performed.Fall to ground and obese ¿ noted in per & prior fractures with revision.Mmi review- there is a fracture of the femoral implant proximally with resulting varus angulation at the fracture site.There is no dislocation.Lucencies are present within the greater trochanter consistent with osteolysis but no definite osseous fracture is identified although given the presence of a prosthesis fracture this cannot be excluded and additional views would be helpful.Cortical thickening and osseous irregularity of the proximal femur appears chronic.Plate and screw fixation of the proximal femur appears intact.There is proximal migration of the femur in relation to the acetabulum.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 or Problem Description
It was reported the patient underwent a hip revision approximately one year post implantation due to the rupture of the prosthesis arcos cone proximal body with sts distal stem.No additional information.

• Brand Name: ARCOS 15X150MM SPL TPR DIST
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10875997
• Report Number: 0001825034-2020-03534
• Device Sequence Number: 3738056
• Product Code: KWA
• UDI-Device Identifier: 00880304474178
• UDI-Public: (01)00880304474178(17)251112(10)907960
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2025
• Device Model Number: N/A
• Device Catalogue Number: 11-300815
• Device Lot Number: 907960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention