MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X45 ST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	180556
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01227.D10: medical products: item#: unknown, unknown screw; lot#: unknown.H3: 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.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to the implant fracturing.This is the patient's third revision surgery and the second time the patient has been revised due to an implant fracturing.Multiple attempts have been made to obtain additional information.No response has been made at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional/corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01227-1, 0001825034-2023-01627, 0001825034-2023-01628, 0001825034-2023-01631.D10: medical products: item#: 180555, comp lk scr 3.5hex 4.75x40 st; lot#: 867190, item#: 180556, comp lk scr 3.5hex 4.75x45 st; lot#: 922110, item#: 180555, comp lk scr 3.5hex 4.75x40 st; lot#: 962390, item#: 115400, comp rvs cntrl 6.5x50mm st/rst; lot#: 343310.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product were not returned by the patient.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 a shoulder arthroplasty on an unknown date.The patient underwent a revision surgery over a year and a half ago due to fractured screws.Subsequently, the patient underwent a second revision surgery due to fractured vrs screws.Patient was implanted with a shoulder hemi.This is the third revision surgery and second surgery due to fracturing of implants.
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: 0001825034-2023-01227-2.0001825034-2023-01627-1.0001825034-2023-01628-1.0001825034-2023-01631-1.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 underwent a second stage revision procedure.Subsequently, the patient underwent a revision procedure due to fractured screws approximately four (4) months post-implantation.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: the reported event was confirmed via provided radiographs.No devices were returned for examination.Upon hcp review of the provided radiographs, it was identified that there were multiple glenoid implant screws fractured, with possibly one screw intact superiorly.The glenoid implant is displaced from the glenoid.There is not dislocation seen.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not be determined.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.

• Brand Name: COMP LK SCR 3.5HEX 4.75X45 ST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 17031043
• Report Number: 0001825034-2023-01228
• Device Sequence Number: 18045800
• Product Code: PHX
• UDI-Device Identifier: 00880304677197
• UDI-Public: (01)00880304677197(17)260201(10)942790
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K130390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 08/29/2023
• 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 Expiration Date: 02/01/2026
• Device Model Number: 180556
• Device Catalogue Number: 180556
• Device Lot Number: 942790
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 06/28/2023; 08/23/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/14/2023; 07/26/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2016
• 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; Hospitalization
• Patient Sex: Male