MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X35MM ST/RST; SCREW, FIXATION

Model Number	115397
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a revision for glenosphere disassociated due to central screw not being seated properly at primary operation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).Report source: foreign: australia.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Cr vivacit-e 36mm brng std cat: 110031424 lot: 64653572 comp lk scr 3.5hex 4.75x30 st cat: 180553 lot: 453310 comp primary stem 11mm mini cat: 113631 lot: 678550 comp rvrs shldr glnsp std 36mm cat: 115310 lot: 400310 comp lk scr 3.5hex 4.75x25 st cat: 180552 lot: 265340 comp lk scr 3.5hex 4.75x15 st cat: 180550 lot: 553390 comp lk scr 3.5hex 4.75x15 st cat: 180550 lot: 498660 mini tray std cocr +3 offset cat: 110031402 lot: 64634024 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g7, h1, h2, h3, h6, h10 radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the initial image shows anatomic alignment of the reverse-type shoulder arthroplasty components although the glenosphere appears asymmetrically positioned on the baseplate.The remaining images show disassociation of the glenosphere with malalignment.There is no osseous fracture or evidence of implant loosening.Device history record was reviewed and no discrepancies 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP RVS CNTRL 6.5X35MM ST/RST
• Common Device Name: SCREW, FIXATION
• 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: 15217907
• Report Number: 0001825034-2022-01846
• Device Sequence Number: 5746322
• Product Code: KWS
• UDI-Device Identifier: 00880304677098
• UDI-Public: (01)00880304677098(17)300304(10)165860
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2022
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 115397
• Device Catalogue Number: 115397
• Device Lot Number: 165860
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 08/16/2022; 11/15/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 09/12/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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; UNKNOWN TAPER/BASEPLATE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female