MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 70MM; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 650-1057 lot# 142150 cer bioloxd option hd36mm.Cat# 650-1066 lot# 571430 cer opt type 1 tpr sleve 0mm.Cat# unk lot# unk 5 cerclage wires.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient had a hip revision due to a right broken stem implant.There were no surgical complications.Though requested, no additional information was available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated.H6: component code: mechanical (g04) - stem.One stem was returned and evaluated.Upon visual inspection, it was noted that the device had fractured at the female taper bottom.There was visible gouging and scratches to the profile of the device, along with scuffing to the face and male taper shaft.The returned hip stem was submitted for fracture analysis.The fracture surface showed smearing and biological debris that obscured the artifacts.However, high magnification imaging revealed striations in multiple areas suggesting that the hip stem fractured due to fatigue.A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: right total hip arthroplasty with long stem from a component which appeared to be fractured at the junction of the femoral neck and proximal femoral stem.A definitive root cause cannot be determined.The event was confirmed via x-rays and returned product 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
No further event information is available at the time of this report.

• Brand Name: ARCOS CON SZ A STD 70MM
• 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: 19010939
• Report Number: 0001825034-2024-00772
• Device Sequence Number: 7981010
• Product Code: KWA
• UDI-Device Identifier: 00880304474314
• UDI-Public: (01)00880304474314(17)260304(10)963440
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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 Expiration Date: 03/04/2026
• Device Model Number: N/A
• Device Catalogue Number: 11-301321
• Device Lot Number: 963440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2016
• 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