MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 10MM MINI; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: 118001, versa-dial/comp ti std taper, lot 293410; 113042, versa-dial 46x18x53 hum head, lot 817810; 113954, md hybrid glenoid base 4mm, lot 356170; pt-113950, pt hybrid glen post regenerex, lot 450770.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 10285.

Event Description

It has been reported that approximately 4 years post implantation, the patient had a complaint of l shoulder pain, mild in nature with overexertion, and radiographs revealed mild lucencies around the superior shaft.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.X-ray review demonstrated lucencies involving the greater tuberosity with peripheral sclerosis.There was also inferior and anterior subluxation of the humeral head with respect to the glenoid.Device history record (dhr) was reviewed and no discrepancies were found.Root cause could not be determined with information available.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

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

• Brand Name: COMP PRIMARY STEM 10MM MINI
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8040050
• MDR Text Key: 126217780
• Report Number: 0001825034-2018-10284
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113630
• Device Lot Number: 380740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 84