MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ C HI 60MM TRL; INSTRUMENT, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02774.0001825034 - 2023 - 02775.0001825034 - 2023 - 02776.0001825034 - 2023 - 02777.0001825034 - 2023 - 02778.0001825034 - 2023 - 02779.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it is required to be available for surgery.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the surgeon that the trials are not properly locking onto the stem anymore.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - stem.Two trials item# 31-301302 lot# 398251 and item# 31-301313 lot# 404634 were returned and evaluated.Upon visual inspection both devices have wear to the face area around the screw hole location.Both of the hex features of the screws are intact.No further testing on the screw could be performed as it couldn't be removed to evaluate for thread damage.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.The event was confirmed on one unit but not on the other six.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

No further information is available at the time of this report.

• Brand Name: ARCOS CON SZ C HI 60MM TRL
• Type of Device: INSTRUMENT, 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: 18226181
• MDR Text Key: 329214548
• Report Number: 0001825034-2023-02780
• Device Sequence Number: 1
• Product Code: KWA
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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: 31-301313
• Device Lot Number: 404634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 88 KG