MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/31/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: csr humeral tray ¿ cat.No.115340, lot no.492370, csr shoulder stem ¿ cat.No.113648, lot no.104520, csr glenosphere ¿ cat.No.115310, lot no.609790, csr humeral bearing ¿ cat.No.Xl-115363, lot no.011140, csr glenosphere baseplate ¿ cat.No.115330, lot no.550050, fixed locking screw ¿ cat.No.180501, lot no.468580.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Product location unknown.

Event Description

It was reported that a patient underwent right total reverse shoulder arthroplasty.Subsequently, the patients glenosphere disassociated.The patient experienced dislocation of the shoulder as well as poly wear.No further information is available at this time.

Event Description

It was reported that a patient underwent right total reverse shoulder arthroplasty.Subsequently, the patient's glenosphere disassociated.The patient experienced dislocation of the shoulder as well as poly wear and loss of function with the arm.No further information is available at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause could not be determined with information available.A contributing condition to the event is patient was being lifted underneath her arm pits for transportation and felt a pop.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 trend.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No device was returned for examination.Medical records were reviewed and confirmed device disassociation and dislocation with associated metallosis.Review of the device history records identified no related deviations or anomalies during manufacturing.Root cause remains undetermined.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: VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7779323
• MDR Text Key: 116997941
• Report Number: 0001825034-2018-05033
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 534460
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 115330 COMPREHENSIVE BASEPLATE, LOT 550050
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR