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

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2024

Event Type  Injury  

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 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.

• Brand Name: SEGMENTAL FLUTED STEM EXTENSION
• Type of Device: 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
• MDR Text Key: 339098035
• Report Number: 3007963827-2024-00094
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024197725
• UDI-Public: (01)00889024197725(17)270525(10)65384594
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K101296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 90 KG