MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN E1 STANDARD HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Concomitant medical products: 115310, comp rvrs shldr glnsp std 36 mm, unknown.Unknown, unknown head, unknown.Customer has been indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-09833.

Event Description

It was reported that a patient underwent an initial reverse shoulder replacement procedure.Subsequently, the patient was revised due to dislocation and pain.During surgery, the surgeon found the glenosphere to be loose.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined this device should not have been reported.The event was a disassociation event, not a dislocation event; therefore, the bearing was not involved.The initial report was submitted in error and should be voided.Event information and device involved in he event has been reported on mfr number 0001825034-2017-09833.

Manufacturer Narrative

This follow up report is being filed in response to an fda request.The report contains additional and corrected information.

Event Description

It was reported that a patient underwent an initial reverse shoulder replacement procedure.The patient reported experiencing pain and a subsequent mri revealed the glenosphere had disassociated from the glenoid baseplate.The patient was revised and during the surgery, the surgeon noted the central screw was not fully seated.The glenosphere was replaced and the central screw was tightened until fully seated.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN E1 STANDARD HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• 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: 6996747
• MDR Text Key: 94237144
• Report Number: 0001825034-2017-09835
• Device Sequence Number: 1
• Product Code: PAO
• 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: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 11/02/2017
• Supplement Dates Manufacturer Received: 11/24/2017; 11/24/2017
• Supplement Dates FDA Received: 11/08/2017; 11/29/2017
• 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): Hospitalization; Required Intervention