MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE GLENOID BASEPLATE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has 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.Concomitant medical products: unknown, unknown inverse/reverse cancellous screw, unknown; 00434904011, glenosphere 40 mm diameter, 63286804; 00434904003, poly liner plus 3 mm offset 40 mm diameter, 62816886; 00434901213, humeral stem 12 mm, 63186644.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06808.

Event Description

It was reported that the patient underwent a primary reverse shoulder arthroplasty.Subsequently, the patient was revised due to the baseplate screws breaking and the baseplate becoming loose and displaced.The baseplate was removed and converted to a hemiarthroplasty with a dual taper adaptor and humeral head.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: TM REVERSE GLENOID BASEPLATE
• 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: 6914273
• MDR Text Key: 88201509
• Report Number: 0001822565-2017-06807
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• 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: 00434901500
• Device Lot Number: 63319128
• Other Device ID Number: (01) 00889024268999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2016
• 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
• Patient Age: 71 YR