MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS 50MM DST HUM BDY RT; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2018 - 10552.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient had ongoing disassociation's that requires future revision.The patient had an open re-engagement and subsequently disassociated again at the same point.It was reported the surgeon deviated from the surgical technique.No further information has been made available at this time.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed via visual examination of the returned distal humeral body.X-rays were reviewed but the quality was too poor to aid in investigation.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is attributed to unintentional user error.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: COMPR SRS 50MM DST HUM BDY RT
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8092099
• MDR Text Key: 128018287
• Report Number: 0001825034-2018-10554
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K153398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110029938
• Device Lot Number: 588290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 211259 COMPR SRS MOD STEM - 9X100MM LOT 639440
• Patient Outcome(s): Hospitalization; Other; Required Intervention