MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ARCOS CONE; PROSTHESIS, HIIP

Model Number N/A

Device Problem Positioning Problem (3009)

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

Event Date 02/27/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source united kingdom.Product location is unknown and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00469.

Event Description

It was reported that during a hip procedure, it was found that the cone body of the femoral component did not provide adequate limb length and offset, so the surgeon attempted to remove it.After numerous attempts were made to engage the disassembly tool with the cone body, it was found that the screw thread was cross threaded.The implant was unable to be removed as planned.The surgeon decided to close the patient, order a different head size and have the patient return to the operating room at another time.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the device is covered in bio-debris.The first thread ring is damaged and there is additional metal debris present in the threads.Complaint confirmed based on evaluation of provided image.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot 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 Description

No additional event information to report at this time.

• Brand Name: UNKNOWN ARCOS CONE
• Type of Device: PROSTHESIS, HIIP
• 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: 16511323
• MDR Text Key: 310948566
• Report Number: 0001825034-2023-00470
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 31-301856 DISASSEMBLY TOOL ZB110902
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Male