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

Catalog Number	180554
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110027734, compr vrs glen pps min tpr adr; lot#: unknown; item#: 115400, comp rvs cntrl6.5x50mm st/rst; lot#: 409840; item#: 180551, comp lk scr 3.5hex 4.75x20 st; lot#: 65699984; item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 65930511; item#: 180555, comp lk scr 3.5hex 4.75x40 st; lot#: 849670.Multiple screws were reported as the reporter was not sure which peripheral screws actually loosened.G2: foreign: japan.H3: 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 the patient underwent an initial shoulder arthroplasty with a vrs system approximately one (1) year ago.The patient developed a postoperative infection approximately nine (9) months later when the poly linear and glenosphere head were replaced.Subsequently, the patient underwent a second revision surgery approximately a month and a half ago due to loosening of the implant.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.D10: medical products: item#: 110027734, compr vrs glen pps min tpr adr; lot#: 66192751.Item#: 180551, comp lk scr 3.5hex 4.75x20 st; lot#: 65699984.Item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 65930511.Item#: 180555, comp lk scr 3.5hex 4.75x40 st; lot#: 849670.Item#: 115400, comp rvs cntrl 6.5x50mm st/rst; lot#: 409840.H11: 0001825034-2024-02306, 0001825034-2024-02307, 0001825034-2024-02308, 0001825034-2024-02310.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.H10: 0001825034-2024-02306-1.0001825034-2024-02307-1.0001825034-2024-02308-1.0001825034-2024-02310-1.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.Follow ups determined that the patient had poor bone quality at the time of loosening, however the bone quality at the time of implantation remains unknown.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 LK 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: 20346446
• Report Number: 0001825034-2024-02309
• Device Sequence Number: 7880156
• Product Code: PHX
• UDI-Device Identifier: 00880304677173
• UDI-Public: (01)00880304677173(17)320320(10)877630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2025

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: 180554
• Device Lot Number: 877630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 02/04/2025; 03/14/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 02/25/2025; 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown