MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 42X18X46 HUM HEAD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	113032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient is to undergo a revision six(6) years post implantation due disassociation and pain.However, no revision procedure has been reported to date.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item#118001 ; lot#139970, item# 113610; lot#115800, item#20-8075-004-01; lot#63178536, item#00-4326-040-46; lot#62700439.Device remains implanted.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02747, 0001825034-2022-02745.
Event or Problem Description
It was reported that a patient underwent a revision six (6) years post implantation due disassociation and pain.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Associated products and reports 0001822565-2022-03533 item# 00-4326-040-46; lot# 62700439.0001822565-2022-03555 item# 20-8075-004-01; lot# 63178536.0001825034-2022-02745-1 item# 113610; lot# 115800.0001825034-2022-02747-1 item# 118001; lot# 139970.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Proposed code: mechanical (g04)- head.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Medical records assessed and timeline created.Review of medical records and mmi were assessed.It is noted that the review is for a linked complaint glenoid fracture and are not corresponding to this complaint.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Associated products and reports ------------------------------------------- 0001825034-2022-02745-2 item#113610; lot#115800 0001825034-2022-02747-2 item#118001; lot#139970 0001822565-2022-03533-1 item00432604046; lot#62700439 0001825034-2023-00191-1 item#113610; lot#115800.
Event or Problem Description
It was reported a patient had initial left total shoulder arthroplasty approximately seven years ago.Subsequently, the patient, underwent stage one of a two stage revision due to pain and a large, non-contained, glenoid defect.During the surgery, the glenoid was found fragmenting and a synovectomy was performed due to synovitis.All components were removed, and a non-zimmer biomet spacer was placed.No further event information available at the time of this report.

• Brand Name: VERSA-DIAL 42X18X46 HUM HEAD
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15959386
• Report Number: 0001825034-2022-02748
• Device Sequence Number: 4938583
• Product Code: MBF
• UDI-Device Identifier: 00880304212206
• UDI-Public: (01)00880304212206(17)250903(10)214780
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2025
• Device Catalogue Number: 113032
• Device Lot Number: 214780
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 12/07/2022; 03/22/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/03/2023; 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10.
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female