MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X21X50 HUM HEAD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a left shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision for an unknown reason on an unknown day.Attempts have been made and it was reported that the case was cancelled.No further information is available form the event at this time.
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional/corrected information.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 the patient underwent an initial left shoulder surgery on an unknown date for an unknown reason.Subsequently, the patient is being considered for a revision surgery due to a tendon tear.
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: 0001825034-2022-01884 medical products: item#: 113952, sm hybrid glenoid base 4mm; lot#: 992960 item#: pt-113950, pt hybrid glen post regenerex; lot#: 964350 item#: 113631, comp primary stem 11mm mini; lot#: 65025650 item#: 118001, versa-dial/comp ti std taper, lot#: 465650 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(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: significant findings include joint instability due to the apparent osteolysis and suspected glenoid implant loosening.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.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
It was reported that the patient was being considered for a revision surgery due to failure of their subscapularis that lead to the patient's gleno humeral joint unstable.

• Brand Name: VERSA-DIAL 46X21X50 HUM HEAD
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/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: 14025425
• Report Number: 0001825034-2022-00842
• Device Sequence Number: 2571577
• Product Code: MBF
• UDI-Device Identifier: 00880304212237
• UDI-Public: (01)00880304212237(17)310819(10)J7089153
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/17/2022
• 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 Model Number: N/A
• Device Catalogue Number: 113044
• Device Lot Number: J7089153
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 04/14/2022; 08/15/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/11/2022; 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female