MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 16 X 150MM STS STEM TRL; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/07/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Device in the process of being returned.

Event Description

It was reported patient underwent a hip revision approximately 8 years post implantation due to a competitors non cemented stem loosening.During the procedure the arcos sts distal trial became stuck in femur.Surgeon had to perform an osteotomy to open the femur to remove the trial, he then had to cable the osteotomy after revision stem implanted.No additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 h6 component code: mechanical (g04) ¿ stem visual examination of the provided pictures identified the provisional has heavy gouging and damage.It is unknown if the damage was present prior to the removal by cutting.Lot identification is necessary for review of device history records; lot identification was not 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 information on the reported event.

• Brand Name: ARCOS 16 X 150MM STS STEM TRL
• Type of Device: PROSTHESIS, 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: 15905770
• MDR Text Key: 304707918
• Report Number: 0001825034-2022-02736
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090757
• 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: 12/08/2022

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
• Device Catalogue Number: 31-300816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male