MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 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	Failure of Implant (1924)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
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.
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.H6: mechanical (g04) - stem.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.

• Brand Name: SEGMENTAL FLUTED STEM EXTENSION
• 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: 19714776
• Report Number: 0001822565-2024-02317
• Device Sequence Number: 12913683
• Product Code: LZO
• UDI-Device Identifier: 00889024197725
• UDI-Public: (01)00889024197725(17)320617(10)65384597
• 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
• 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: 65384597
• 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: 07/02/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 90 KG