MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hip Fracture (2349)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown head.Unknown cup.The complaint is under investigation.Once the investigation is completed a follow up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial right hip arthroplasty and was revised due to pain, metallosis, elevated metal ion levels, and pseudotumor.During the revision, while extracting the head and stem, the lesser and greater trochanter fractured.Cavitary defects had been noted in the greater trochanter.Plate and screws were used to reduce the fracture.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of operative notes.Revision op notes noted that the femoral head could not be dislodged from the femoral component.The removal of both the femoral head and stem led to a femoral fracture.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was 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.Multiple mdr reports were filed for this event, please see associated reports 0001825034-2019-02011.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8200144
• MDR Text Key: 131544398
• Report Number: 0001825034-2018-11548
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 04/23/2019
• Supplement Dates FDA Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR