MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X15 ST; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 110032420, comp aug mini bsplt w tpr md, lot # 65967500.Catalog #: 113633, comp primary stem 13mm mini, lot # 65909490.Catalog #: 115396, comp rvs cntrl 6.5x30mm st/rst, lot # 66653740.Catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 65905100.Catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 66725694.Catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 66817100.Catalog #: 110031399, offset 40mm diameter humeral tray, lot # 66854570.Catalog #: 110030776, standard offset 40mm diameter glenosphere, lot # 66238806.Catalog #: 110031427, standard 40mm diameter bearing, lot # 66786451.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 a patient underwent a shoulder arthroplasty approximately one month ago.Subsequently, the patient was revised 8 days later due to instability and loosening.Patient had new stem and taper put in.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated:.The following sections was corrected: a2; h4 h10: related report number: 0001825034-2025-00068 0001825034-2025-00071 0001825034-2025-00069 0001825034-2025-00072 0001825034-2025-00073 0001825034-2025-00074.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.Medical records were not provided.Root cause is attributed to user error, off label use.Per the instructions for use ifu 01-50-1284, 01-50-0890, and 01-50-0903 "humeral and glenosphere components should be used only when there is good quality bone." and it was noted that the patient had poor bone quality due to renal failure.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 4.75X15 ST
• Common Device Name: EXTREMITY IMPLANT
• 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: 21095594
• Report Number: 0001825034-2025-00070
• Device Sequence Number: 21012974
• Product Code: KWS
• UDI-Device Identifier: 00880304677135
• UDI-Public: (01)00880304677135(17)340215(10)66554397
• 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
• 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
• Report Date (Section B): 06/26/2025

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 Model Number: N/A
• Device Catalogue Number: 180550
• Device Lot Number: 66554397
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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: H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male