MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A HI 70MM; 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: 11-300817 arcos 17x150mm spl tpr dist 294520.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated report(s): 0001825034-2018-00790.

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 CON SZ A HI 70MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7268307
• MDR Text Key: 99983004
• Report Number: 0001825034-2018-00789
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• 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 Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 11-301331
• Device Lot Number: 490360
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 60