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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure eight months post implantation due to infection and femoral fracture.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: polyethylene insert xt size c use with distal femoral xt size c use with xt only catalog # 00585001396 lot # 65521752.Articular surface with segmental hinge post size c 12 mm height catalog # 00585003012 lot # 65617170.Fluted stem extension straight precoat 9 mm diameter 130 mm length for cemented use only catalog # 00585205009 lot # 65617232.Proximal tibial component (tibial body x1 tibial bushing x1) size 3 for cemented use only in the u.S.A.Catalog # 00585000310 lot # 63859283.All poly petella catalog # 00597206538 lot # 64774939.Stem collar 35 mm o.D.For use with 16 mm or smaller diameter segmental stems catalog # 00585204035 lot # 65466071.Fluted stem extension straight precoat 11 mm diameter 130 mm length for cemented use only catalog # 00585205011 lot # 65055137.Stem collar 25 mm o.D.For use with 16 mm or smaller diameter segmental stems catalog # 00585204025 lot # 65530735.Depuy cmw bone cement catalog # 3325-040 lot # 3836837.Optip 80 refob plus bone cmt-3 catalog # 4722502117-3 lot # zx15bd1106.G2: australia.H3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - femur).Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of use and femoral has proximal tabs of the implant fractured off.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 that implant fit is maintained but there is marked malalignment following the femoral implant fracture/disassembly.Bone quality appears osteopenic on all images.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
It was reported patient underwent a revision procedure eight months post implantation due to femoral fracture.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: DISTAL FEMORAL XT COMPONENT WITH POLYETHYLENE INSERT
• 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: 18084052
• Report Number: 0001822565-2023-03076
• Device Sequence Number: 15385955
• Product Code: KRO
• UDI-Device Identifier: 00889024195943
• UDI-Public: (01)00889024195943(17)320808(10)65550951
• 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: 2023
• Device Explanted Year: 2023
• 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): 04/04/2024

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: 00585004301
• Device Lot Number: 65550951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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 Sex: Female
• Patient Weight: 142 KG