MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN BI-METRIC POROUS PRIMARY HIP; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

Patient's right hip was revised due to periprostetic fracture.During the revision, the femoral head and stem were removed and replaced.

Manufacturer Narrative

(b)(6).This follow-up report is being filed to relay corrected and additional information.Reported event was confirmed through a review of radiographs.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 as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN BI-METRIC POROUS PRIMARY HIP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; .; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6214252
• MDR Text Key: 63588755
• Report Number: 0001825034-2016-05432
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• 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: 06/09/2017

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: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2017
• 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
• Patient Age: 89 YR