MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 12MM STD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Defective Device (2588); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 12/21/2018

Event Type  malfunction  

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 was reported that during the initial reverse total shoulder arthroplasty, the implant sat 1 mm proud during implantation, following broaching.A new, smaller implant of the next lowest size was used to completed the procedure.A delay of thirty five (35) minutes was noted.No additional patient consequences were noted.No additional information is available at this time.

Event Description

No additional information is available to report at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Upon visual inspection of stem there was no visible damage.Overall length and two section widths taken and found in conformance.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP PRIMARY STEM 12MM STD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8251128
• MDR Text Key: 133183360
• Report Number: 0001825034-2019-00044
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• 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: 113652
• Device Lot Number: 899030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 52