MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BGS GPS II PLATELET SEPARATION SYSTEM; EQUIPMENT, LABORATORY, GENERAL PURPOSE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Literature initial reporter: joseph e.Broyles, m.Adaire o¿brien, stephanie t.Broyles and m.Patrick stagg ¿biologic augmented microdrilling surgery for multiple and large full-thickness cartilage lesions in the knee: early clinical and radiological results¿ surgical science, 2017, 8, 102-117 http://www.Scirp.Org/journal/ss.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A 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.

Event Description

It was reported in a journal article that two patients experienced a decrease in joint space.No additional patient consequences were reported.

Manufacturer Narrative

Upon further review, this event was confirmed to be caused by products other than zimmer biomet products.

Manufacturer Narrative

Previous submission stating not related to zimmer biomet products was sent in error.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported in a journal article that two patients experienced a decrease in joint space, following biologic augmented microdrilling surgery for symptomatic cartilage defects of the knee.No further information was provided.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional information.The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this 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.

• Brand Name: BGS GPS II PLATELET SEPARATION SYSTEM
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7075230
• MDR Text Key: 93478356
• Report Number: 0001825034-2017-10757
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/15/2018

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: 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
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 01/26/2018; 02/14/2018; 02/15/2018
• Supplement Dates FDA Received: 01/26/2018; 02/14/2018; 02/22/2018
• 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): Other