MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN HEAD; HIP, PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 12/14/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Chammout, g.Et al.(2016).More complications with uncemented than cemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly.Acta orthopaedica, 88 (2), 145-151.Doi 10.1080/17453674.2016.1262687.Report source, foreign - event occurred in (b)(6).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 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 04891, 0001825034 - 2017 - 04893, 0001825034 - 2017 - 04895.

Event Description

It is reported that two patients expired during study period.The timeframe between patient death and total hip arthroplasty procedure is unknown.No additional information provided.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN HEAD
• Type of Device: HIP, PROSTHESIS
• 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 ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6707352
• MDR Text Key: 79830620
• Report Number: 0001825034-2017-04894
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2017
• 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
• Treatment: UNKKNOWN BI METRIC STEM; UNKNOWN CUP; UNKNOWN LINER
• Patient Outcome(s): Death