MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A HI 50MM; 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 devices: 36mm cocr mod hd -6mm cat# 11-363660 lot# 035250; arcos 15x150mm spl tpr dist cat# 11-300815 lot# 907960.Foreign: country: (b)(6).Complaint sample was evaluated and the reported event was confirmed.The fractured piece of stem remains assembled with the cone body by the stem screw.The polished surfaces on the sides of the body are scratched.The associated head also remains assembled with the body.Sem analysis of cone body fracture on a hip stem sample showed that the fracture surface was covered with biological debris which obscured the fracture artifacts and that the mode of failure could not be determined.However, the fracture suspected to have caused by fatigue due to the presence of ratchet mark like indication though it couldn¿t be verified further as the debris obscured the fracture artifacts.Medical records/radiographs were provided and reviewed by a health care professional.Right femur sub-trochanteric fracture repaired with arcos stem and 4 unk cables.Subsequently implant fracture occurred post fall to ground, revision later performed.Radiographs were reviewed and revealed 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 arcos cone proximal body with sts distal stem as a result of a fall.No additional information.

• Brand Name: ARCOS CON SZ A HI 50MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10837283
• Report Number: 0001825034-2020-03533
• Device Sequence Number: 4141494
• Product Code: KWA
• UDI-Device Identifier: 00880304473799
• UDI-Public: (01)00880304473799(17)251006(10)514810
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

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: 10/06/2025
• Device Model Number: N/A
• Device Catalogue Number: 11-301310
• Device Lot Number: 514810
• 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: 11/13/2020
• 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