MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP NLK SCR 3.5HEX 4.75X40 ST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	180562
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty with non-zimmer biomet products on and unknown date.The patient then underwent a revision surgery approximately one (1) year ago due to an unknown reason.Subsequently, several months after the revision surgery, there appeared to be loosening of the glenoid implants.The patient will undergo a revision surgery on an unknown date.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 66053299; item#: 115397, comp rvs cntrl 6.5x35mm st/rst; lot#: 66082758; item#: 180559, comp nlk scr 3.5hex 4.75x25 st; lot#: 66127676; item#: 180562, comp nlk scr 3.5hex 4.75x40 st; lot#: 859790; item#: 180561, comp nlk scr 3.5hex 4.75x35 st; lot#: 66138820; item#: 180559, comp nlk scr 3.5hex 4.75x25 st; lot#: 66127676; item#: 115316, comp rvrs shldr glnsp +6 36mm; lot#: 135990; item#: 00-4349-010-17, tm reverse stem 10mm x 170mm; lot#: 65550644; item#: 00-4349-036-00, 36mm poly liner plus 0mm ofs; lot#: 65871436.G2: foreign: france.H10: 0001825034-2024-02361-1, 0001825034-2024-02362-1, 0001825034-2024-02363-1, 0001825034-2024-02364-1, 0001825034-2024-02365-1, 0001825034-2024-02366-1.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: reverse total shoulder arthroplasty with fracture glenoid screws but no dislocation.Sizing is appropriate.There are multiple fractured glenoid screws from a reverse total shoulder arthroplasty.It was noted that 5 peripheral screws were invoiced per usage and sticker sheets.The baseplate only has openings for 4.However, it is unknown which item was not implanted and why it was not used.As such, 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.

• Brand Name: COMP NLK SCR 3.5HEX 4.75X40 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: 20924832
• Report Number: 0001825034-2024-02941
• Device Sequence Number: 20100795
• Product Code: PHX
• UDI-Device Identifier: 00880304677296
• UDI-Public: (01)00880304677296(17)320808(10)919680
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 180562
• Device Lot Number: 919680
• 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: 12/11/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Male