MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP CONV GLEN LINER VIVACIT-E; PROSTHESIS, SHOULDER

Model Number	110035767
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat: 113032, lot: j7347703 ,versa-dial 42x18x46 hum head, cat: 118001, lot: j7252716, versa-dial/comp ti std taper.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded by the hospital.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: 0001822565-2023-00050.
Event or Problem Description
It was reported that the patient was revised due to disassociation of baseplate and poly.Further, the surgeon also stated that the post was sheared off.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of pictures.Visual examination of the provided photograph identified that the liner post appears to be fractured and wear is noted from use.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
This event will be further reported under the correct mfr# 1825034.The previous reports were forwarded in error and should be voided.
Additional Manufacturer Narrative
This event will be further reported under the correct mfr# (b)(4).The previous reports were forwarded in error and should be voided.

• Brand Name: COMP CONV GLEN LINER VIVACIT-E
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16130106
• Report Number: 0001822565-2023-00051
• Device Sequence Number: 3238362
• Product Code: KWS
• UDI-Device Identifier: 00887868249334
• UDI-Public: (01)00887868249334(17)260923(10)65087003V
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K211729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2026
• Device Model Number: 110035767
• Device Catalogue Number: 110035767
• Device Lot Number: 65087003V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 04/13/2023; 04/19/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 04/13/2023; 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male