MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, EXTREMITIES

Catalog Number 118001

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Inflammation (1932)

Event Date 11/30/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery approximately four (4) years and one (1) month post-implantation due to rotator cuff failure and loose glenoid component.Surgeon stated that at the time of the primary implantation, the patient had undiagnosed inflammatory arthropathy.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03417, 0001825034-2021-03418.Concomitant medical products: item# 113954; lot# 996800.Item# pt-113950; lot# 241890.Item# 115330; lot# 734280.Item# 405889; lot# 321360.Item# 405883; lot# 291840.Item# 405800; lot# 579190.Item# 115395; lot# 346230.Item# 180554; lot# 705840.Item# 180550; lot# 464210.Item# 180552; lot# 697300.Item# 180550; lot# 787440.Item# 118001; lot# 386740.Item# 115310; lot# 244620.Item# 110031424; lot# 64980771.Item# 110031399; lot# 65142051.Item# 110004347; lot# 770440.Item# 113042; lot# 594640.Item# 115736; lot# 866520r.Item# 20-8000-000-11; lot# 63706262.Report source: foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.Taper adapter is not related to glenoid loosening, therefore the device was not involved in the reported event.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: VERSA-DIAL/COMP TI STD TAPER
• Type of Device: PROSTHESIS, EXTREMITIES
• 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: 13087664
• MDR Text Key: 282774742
• Report Number: 0001825034-2021-03419
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249(17)261201(10)256620
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 118001
• Device Lot Number: 256620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 75 KG