MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 12X150MM SPL TPR DIST; PROSTHETIC, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that after robust reaming of the femoral canal, the stem seated unacceptably lower than the reamer.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the stem to be in decent overall condition.Scratching around the taper and screw hole was the only damage observed.The locking screw was not returned with the stem.Measurements were taken for the cross section at two locations and overall length.All of the results were found to meet the print specifications.Unable to confirm complaint as the returned device is conforming per specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.No device problem was found.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

There is no update to the prior event description provided.

• Brand Name: ARCOS 12X150MM SPL TPR DIST
• Type of Device: PROSTHETIC, 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: 18290351
• MDR Text Key: 330006753
• Report Number: 0001825034-2023-02899
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304468078
• UDI-Public: (01)00880304468078(17)330221(10)65737347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-300812
• Device Lot Number: 65737347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1