MAUDE Adverse Event Report: BIOMET UK LTD. UNK TAPERLOC UNCEMENTED STEM; HIP PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).'displaced intracapsular neck of femur fractures: outcome of 810 hydroxyapetite coated (hac) uncemented hemiarthroplasties' by s.Z nawaz, frcs (tr+ orth) mbbs bsc hons, a.J keightley, a desai, j.Granville-chapman, d.Elliott, k.Newman, a.Khaleel; https://doi.Org/10.1016/j.Injury.2016.10.012.The product and lot number identification necessary to review manufacturing history and the complaint history was not provided.Current information is insufficient to permit conclusion as to the cause of the event.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.Product not returned.

Event Description

It has been reported in a journal article that 5 patients underwent hip revision surgeries due to periprosthetic fracture.

• Brand Name: UNK TAPERLOC UNCEMENTED STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8459174
• MDR Text Key: 140134499
• Report Number: 3002806535-2019-00313
• Device Sequence Number: 1
• Product Code: JDI
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/28/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention