MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X24X47 HUM HEAD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES

Model Number	113046
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01966, 0001825034-2022-01968, and 0001825034-2022-01969.Medical products: item#: unknown, unknown comprehensive small hybrid glenoid; lot#: unknown, item#: unknown, unknown humeral stem, lot#: unknown, item#: unknown, unknown regenerex post; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision surgery for an unknown reason on an unknown date.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01966-1, 0001825034-2022-01968-1, 0001825034-2022-01969-1, 0001825034-2022-02593.D10: medical products: item#: 113952, sm hybrid glenoid base 4mm; lot#: 592850; item#: 113631, comp primary stem 11mm mini; lot#: 527120; item#: pt-113950, pt hybrid glen post regenerex; lot#: 768240; item#: 118001, versa-dial/comp ti std taper; lot#: 223190.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a right shoulder arthroplasty approximately six (6) years ago.Subsequently, the patient is being considered for a revision surgery due to excessive glenoid retroversion.However, no revision procedure has been reported to date.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01966-2 0001825034-2022-01968-2 0001825034-2022-01969-2 0001825034-2022-02593-1 the following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6 h6: component codes: mechanical (g04) - head no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.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 available at the time of this report.

• Brand Name: VERSA-DIAL 46X24X47 HUM HEAD
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES
• 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: 15310260
• Report Number: 0001825034-2022-01967
• Device Sequence Number: 11440799
• Product Code: MBF
• UDI-Device Identifier: 00880304212244
• UDI-Public: (01)00880304212244(17)260325(10)519180
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 12/02/2022
• 2 Devices were Involved in the Event: 1 2

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: 03/25/2026
• Device Model Number: 113046
• Device Catalogue Number: 113046
• Device Lot Number: 519180
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 11/28/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 11/15/2022; 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2016
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown