MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP VRSDL GLNSPR 41MM +6 TI; PROSTHESIS, SHOULDER

Model Number	TI-115326
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat: 115330, lot: unknown, comp rvrs shdr glen bsplt +ha; cat: 118001, lot: unknown, versa-dial/comp ti std taper.Report source: foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2022-00176, 0001825034-2022-00177.
Event or Problem Description
It was reported that the patient underwent a third revision due to implant disassembly.No additional patient consequences were reported.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: COMP VRSDL GLNSPR 41MM +6 TI
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13358443
• Report Number: 0001825034-2022-00178
• Device Sequence Number: 11946377
• Product Code: KWS
• UDI-Device Identifier: 00880304687622
• UDI-Public: (01)00880304687622
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K080642
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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-115326
• Device Catalogue Number: TI-115326
• Device Lot Number: UNKNOWN
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/24/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male