MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. SEGMENTAL FLUTED STEM EXTENSION; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: zss distal femoral xt component ,catalog # 00585004302, lot # 65346318.Stem collar 35 mm o.D., catalog # 00585204035, lot # 65299919.Size 3 precoat non-modular cemented tibial component, catalog # 00588000302 lot # 64429075 seg dist fem poly box sz c, catalog # 00-5850-013-96, lot # 65473912.Prc tib block 5mm sz4, catalog # 00-5988-004-26, lot # 64678239.Prc tib block 5mm sz4, catalog # 00-5988-004-26, lot # 64632306.All poly pat comp 38dia, catalog # 00-5972-065-38, lot # 64843454.Psn 2.5mm female scr 25mm 2pk, catalog # 42-5099-025-25, lot # 65390791.Headless trocar drill pin 75mm, catalog # 00-5901-020-00, lot # 65396809.Psn 2.5mm female scr 25mm 2pk, catalog # 42-5099-025-25, lot # 65382100.Seg fluted stem 11x130mm str, catalog # 00-5852-050-11, lot # 65384597.Segmental art surf sz c 26mm, catalog # 00-5850-030-26, lot # 63125154.G2: australia.H3: customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2024-01118 and 0001822565-2024-01119.
Event or Problem Description
It was reported patient underwent a revision procedure eighteen months post implantation due femoral loosening.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
Upon receipt of additional information, the initial report was submitted under incorrect manufacturing site.This report will be completed under manufacturing report number 1822565.
Event or Problem Description
Upon receipt of additional information, the initial report was submitted under incorrect manufacturing site.This report will be completed under manufacturing report number 1822565.

• Brand Name: SEGMENTAL FLUTED STEM EXTENSION
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19018728
• Report Number: 3007963827-2024-00094
• Device Sequence Number: 18150821
• Product Code: LZO
• UDI-Device Identifier: 00889024197725
• UDI-Public: (01)00889024197725(17)270525(10)65384594
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 07/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585205011
• Device Lot Number: 65384594
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 90 KG