MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP NLK SCR 3.5HEX 4.75X35 ST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	180561
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); 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#: unknown, item#: 115397, comp rvs cntrl 6.5x35mm st/rst; lot#: unknown, item#: 180559, comp nlk scr 3.5hex 4.75x25 st; lot#: unknown, item#: 180562, comp nlk scr 3.5hex 4.75x40 st; lot#: unknown, item#: 180559, comp nlk scr 3.5hex 4.75x25 st; lot#: unknown, item#: 115316, comp rvrs shldr glnsp +6 36mm; lot#: unknown, item#: 00-4349-010-17, tm reverse stem 10mm x 170mm; lot#: unknown, item#: 00-4349-036-00, 36mm poly liner plus 0mm ofs; lot#: unknown.G2: foreign: france h3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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#: 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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.The following sections were updated: d10: medical products: item#: 180562, comp nlk scr 3.5hex 4.75x40 st; lot#: 919680.H10: related report numbers: 0001825034-2024-02361-1 0001825034-2024-02362-1 0001825034-2024-02363-1 0001825034-2024-02364-1 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP NLK SCR 3.5HEX 4.75X35 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: 20397692
• Report Number: 0001825034-2024-02365
• Device Sequence Number: 16988953
• Product Code: PHX
• UDI-Device Identifier: 00880304677289
• UDI-Public: (01)00880304677289(17)330627(10)66138820
• 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): 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): 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: 180561
• Device Lot Number: 66138820
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 12/11/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/23/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2023
• 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 NARRATIVE; SEE H11; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male