MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP VRSDL GLNSPR 36MM TI; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	TI-115310
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02545, 0001825034-2022-02546, 0001825034-2022-02547, 0001825034-2022-02567.Concomitant medical products: item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 634750, item#: 115340, comp rvs hmrl ti tray 44mm; lot#: 738490, item#: xl-115365, arcom xl 44-36 rtnv+3 hmrl brg; lot#: 361080, item#: 113633, comp primary stem 13mm mini; lot#: 336010, item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 628290, item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 628290, item#: 115394, comp rvs cntrl 6.5x20mm st/rst; lot#: 011400.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 a patient underwent a left shoulder revision surgery approximately one (1) week after undergoing an initial revision surgery due to an unknown reason.
Additional Manufacturer Narrative
Cmp-(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: 0001825034-2022-02545-1.0001825034-2022-02546-1.0001825034-2022-02547-1.0001825034-2022-02567-1.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.Medical records were not provided.A definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.
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: 0001825034-2022-02545-2, 0001825034-2022-02547-2, 0001825034-2022-02567-2.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 approximately 6 weeks post implantation, the patient was revised due to loosening and dislocation of their shoulder arthroplasty products.Attempts have been made and no further information has been provided.
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: 0001825034-2022-02545-3, 0001825034-2022-02547-3, 0001825034-2022-02567-3.H6: 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.Medical records were not provided.Previous root cause remains unchanged, a definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP VRSDL GLNSPR 36MM TI
• 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: 15770650
• Report Number: 0001825034-2022-02544
• Device Sequence Number: 6620643
• Product Code: KWS
• UDI-Device Identifier: 00880304687578
• UDI-Public: (01)00880304687578(17)290215(10)621130
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• 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): 10/25/2023

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 Model Number: TI-115310
• Device Catalogue Number: TI-115310
• Device Lot Number: 621130
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 02/27/2023; 05/03/2023; 10/17/2023
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 03/01/2023; 05/24/2023; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown