MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X150MM SPL TPR DIST; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient underwent previous right femur nailing post traumatic slip/fall.The competitor nail was noted to have fractured and was converted to right tha.Post reaming and during trialing it was noted under fluoroscopy that an intraoperative proximal femur fracture occurred.5 cerclage cables were placed.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.The following sections were updated/corrected.Updated: d4, h2; h3; h4, h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: complication of intraoperative fracture of proximal femur with cables placed for fixation.Notes debris from surgery, as well as nonunion of the fracture was debrided.Cup placed and stem, during trial reduction noted fracture of femur under fluoroscopy, surgeon notes 'fracture likely from the impaction comminuted type fracture of the femur proximal to the upper half of the stem.5 cables placed, and components placed.Under fluoroscopy 'stem sat a little bit deeper than prior, as anticipated from fracture'.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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 further event information available at the time of this report.

• Brand Name: ARCOS 15X150MM SPL TPR DIST
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12303262
• MDR Text Key: 265885602
• Report Number: 0001825034-2021-02365
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-300815
• Device Lot Number: 967600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN INTERTAN NAIL; UNKNOWN SCREWS; UNKNOWN INTERTAN NAIL; UNKNOWN SCREWS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 57