MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS STS DIST STEM 13X250MM M; PROSTESIS, HIP

Catalog Number	11-301013
Medical Device Problem Codes	Degraded (1153); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was requested but not returned by hospital.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 concomitant medical products: item# 11-301304 /arcos con sz d std/ lot # 389230.Item # unknown / unknown screw/lot # unknown.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2021 - 02746.
Event or Problem Description
It was reported that the surgeon prepared and implanted the distal stem.The proximal reamer was used to prepare the proximal femur.The surgeon reamed up to d.The d 60 standard was implanted with the green proximal body inserter handle and then using the torque limiting t handle the screw was screwed down.Reduction was done with implants in place.The surgeon needed to change the version of the proximal body.He was handed the 3.5 driver to undo the screw and could not remove the screw it was stripped.He needed to remove the whole construct and replace the items with new ones.No adverse consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ARCOS STS DIST STEM 13X250MM M
• Common Device Name: PROSTESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12541461
• Report Number: 0001825034-2021-02745
• Device Sequence Number: 6157828
• Product Code: KWA
• UDI-Device Identifier: 00880304480346
• UDI-Public: (01)00880304480346(17)301204(10)932000
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11-301013
• Device Lot Number: 932000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/28/2021
• 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