MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM VERSA-DIAL TAPER ADAPTOR; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	03/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog #: 110031424, cr vivacit-e 36mm brng std, lot # 64590250.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It has been reported patient underwent initial shoulder arthroplasty.Subsequently patient was revised due to patient felt pop during normal activities and disassociation of the gelenosphere two weeks post primary implantation.Finally the patient returned to the doctor's office seven (7) days later with same complaint and x-ray shows glenosphere has disassociated from baseplate again.The patient underwent another revision ten (10) days after the first revision again due to disassociation.No additional information is available.
Additional Manufacturer Narrative
(b)(4).Reported event was considered confirmed as the x-rays showed that the glenosphere dissociated from the baseplate.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: 0001825034-2020-02322.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 25MM VERSA-DIAL TAPER ADAPTOR
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9915425
• Report Number: 0001825034-2020-01291
• Device Sequence Number: 11465029
• Product Code: KWS
• UDI-Device Identifier: 00880304531048
• UDI-Public: (01)00880304531048(17)260902(10)521280
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K120121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 09/02/2026
• Device Model Number: N/A
• Device Catalogue Number: 118000
• Device Lot Number: 521280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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; Required Intervention