MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 17X150MM SPL TPR DIST; PROSTHESIS, HIP

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bone Fracture(s) (1870); Blood Loss (2597)

Event Date 10/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-301331 arcos con sz a hi 70mm 490360.A follow up mdr report will be submitted, once the investigation has been completed.Multiple mdr reports were filed for this event, please see associated report(s): 0001825034-2018-00789.Investigation in process.

Event Description

It was reported that during a right hip revision, the patient experienced extension of a previous periprosthetic fracture as the stem was impacted.A plate, screws, and cables were implanted to fix the fracture.The patient required a blood transfusion due to an estimated blood loss of 1100-1500 ml during the procedure.No further information has been provided.

Manufacturer Narrative

The follow up report is submitted to relay additional information received.The complaint was confirmed based on the surgical op notes and x-rays that were provided.X-ray review shows the distal tip of hip arthroplasty noted with a periprosthetic fracture fragment medially which extends to the medial cortex, but this may just be a bone fragment related to surgery.Device history record reviewed and identified no deviations or anomalies.A root cause of the reported issue is 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.

• Brand Name: ARCOS 17X150MM SPL TPR DIST
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7268305
• MDR Text Key: 99982594
• Report Number: 0001825034-2018-00790
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 11-300817
• Device Lot Number: 294520
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 60