MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZSS DISTAL FEMORAL XT COMPONENT; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: fluted stem extension catalog # 00585205011, lot # 65384594.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: 3007963827-2024-00094 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
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h11.H6: mechanical (g04) - femur.Reported event was confirmed by review of radiographs.Visual examination of the provided pictures identified the explants are assembled with foreign material on their surfaces.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.X-ray review indicates there is hinged prosthesis right total knee arthroplasty with loosening of the femoral component.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: ZSS DISTAL FEMORAL XT COMPONENT
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19018719
• Report Number: 0001822565-2024-01118
• Device Sequence Number: 7981272
• Product Code: KRO
• UDI-Device Identifier: 00889024195950
• UDI-Public: (01)00889024195950(17)320323(10)65346318
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150028
• 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: 00585004302
• Device Lot Number: 65346318
• 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: 07/03/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 90 KG