MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 110032410, comp aug mini bsplt w tpr sm, lot # 66215731.Catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 66392745 x 2.G2: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.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 the underwent a right shoulder replacement approximately 2 months ago.The patient had presented to the emergency room and imaging revealed that the baseplate, screws, and glenosphere had migrated out of the patient's glenoid, secondary to fracture.The surgeon indicated the fracture likely was from the primary procedure.Therefore, the patient was revised approximately 3 weeks ago due to a bone fracture.The humeral stem, humeral tray, and humeral bearing remained in situ.The surgeon deemed the glenoid to be unsalvageable due to the fracture.Therefore, the surgeon packed the glenoid with synthetic bone graft and used a mini humeral tray and bearing with an oversized humeral head for salvage hemi-arthroplasty.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).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 further reported that the surgeon may have perforated the far cortex when reaming / impacting the baseplate during the primary procedure, which could have contributed to the reported event.
Additional Manufacturer Narrative
(b)(4).D10: medical product: catalog #: 115395, comp rvs cntrl 6.5x25mm st/rst, lot # 66311624.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.It was indicated that the bone may have been fractured on implantation.However, with the information available, 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: COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 19643186
• Report Number: 0001825034-2024-01712
• Device Sequence Number: 6557809
• Product Code: KWS
• UDI-Device Identifier: 00880304677142
• UDI-Public: (01)00880304677142(17)331130(10)66392745
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/10/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 180551
• Device Lot Number: 66392745
• 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: 06/01/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 09/26/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/30/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown