MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 42X18X46 HUM HEAD; PROSTHESIS, SHOULDER

Model Number	113032
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: 110035767, lot: 65087003v, comp conv glen liner vivacit-e, 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: 0001822565-2023-00051.
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.Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: VERSA-DIAL 42X18X46 HUM HEAD
• 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: 16129990
• Report Number: 0001822565-2023-00050
• Device Sequence Number: 7654930
• Product Code: KWS
• UDI-Device Identifier: 00880304212206
• UDI-Public: (01)00880304212206(10)J7347703
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K040610
• 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
• Report Date (Section B): 04/13/2023

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 Model Number: 113032
• Device Catalogue Number: 113032
• Device Lot Number: J7347703
• 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: 04/12/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 04/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male