MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X30MM ST/RST; SHOULDER, PROSTHESIS

Catalog Number	115396
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.H3 other text : product not returned.
Event or Problem Description
It was reported that the patient is being considered for a revision due to unknown reasons.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that the patient is being considered for a revision due to screw fracture.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, d2, d4, g1-2, g3, g4, g7, h1, h2, h4, h6, h10.D10: comp lk scr 3.5hex 4.75x35 st cat: 180554 lot: 65700031.Comp lk scr 3.5hex 4.75x35 st cat: 180554 lot: 161090.Comp lk scr 3.5hex 4.75x35 st cat: 180554 lot: 905700.Comp lk scr 3.5hex 4.75x35 st cat: 180554 lot: 760800.Comp lk scr 3.5hex 4.75x20 st cat: 180551 lot: 429670.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, d2, g1-2, g3, g7, h1, h2, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to user error as the patient was lifting a hot water heater post-op.Per ifu, "excessive, unusual and/or awkward movement and/or activity, trauma, excessive weight, and obesity have been implicated with premature failure of certain implants by loosening, fracture, dislocation, subluxation and/or wear." the reported event is confirmed as the patient was lifting a hot water heater post-op causing the screw to fracture.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 6.5X30MM ST/RST
• Common Device Name: SHOULDER, PROSTHESIS
• 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: 18382688
• Report Number: 0001825034-2023-03055
• Device Sequence Number: 12387207
• Product Code: KWS
• UDI-Device Identifier: 00880304677081
• UDI-Public: (01)00880304677081(17)320826(10)036680
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/06/2024
• 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 Catalogue Number: 115396
• Device Lot Number: 036680
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 12/28/2023; 04/22/2024; 05/23/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/17/2024; 05/21/2024; 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male