MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE HUMERAL STEM¿MINI 11MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that during comprehensive shoulder arthroplasty, the 11mm mini humeral stem sat 4mm proud, after broaching.Surgery was completed using a 10mm mini stem.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Complaint sample was evaluated and the reported event was not confirmed.Product was returned for evaluation and as per visual inspection showed any no visible damage.Dimensions taken are within specifications.Dhr was reviewed and no discrepancies were found.Device analysis indicated that the device met specification.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: COMPREHENSIVE HUMERAL STEM¿MINI 11MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8125856
• MDR Text Key: 129086475
• Report Number: 0001825034-2018-11027
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• 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: 113631
• Device Lot Number: 480780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 91