MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL DISTAL AUGMENT CEMENTED SIZE 5, 5+ 10 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient is experiencing pain, erythema, swelling, femoral loosening and periprosthetic, medial femoral condyle fracture approximately four years post implantation.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).D10-medical product articular surface fixed bearing (cps) left 14 mm height.Item# 42512600414 lot# 64647779.Femur cemented standard left size 5 , item# 42504605801, lot# 64802575.Femoral distal augment cemented size 5, 5+ 10 mm thickness, item# 42556605810 lot# 64624179.Stem extension tapered cemented 14 mm diameter +75 mm length, item# 42560007514, lot# 64835176.Tibia fixed cemented left size d stem, item# 42542006701, lot# 64649491.Tibial central cone size small, item# 42545000511, lot# 64627892.Tibial augment cemented half block left lateral size cd 15 mm thickness item# 42555803115, lot# 64728967.Tibial augment cemented half block left medial size cd 15 mm thickness item# 42555803315, lot# 64739726.Stem extension tapered cemented 14 mm diameter +75 mm length item# 42560007514 lot# 64835176.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, and h11.Corrected: d4 (lot number, expiration date, udi).
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.D4: attempts have been made to gather all product identification information, and no further information has been provided.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: office note: ct triple phase spect imaging shows loosening of the femoral implant.There is an area of uptake in signal along the distal medical femoral condyle at the supracondylar region that may indicate a fracture, excruciating pain.Next office note: periprosthetic fracture non-displaced medial femoral condyle, does not feel like pain is improving, x-rays: "ap, lateral and sunrise views of the knee arthroplasty show implant in good position and alignment with no gross evidence of failure or loosening." callus formation, symptoms improving, "i do not believe it is necessary to move forward with a revision surgery if she is starting to feel better.I do think there is a chance she could heal this up.I do not think she will have catastrophic failure." will hold off on revision for now.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.This complaint is confirmed with medical records provided.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue.To monitor for trends.

• Brand Name: FEMORAL DISTAL AUGMENT CEMENTED SIZE 5, 5+ 10 MM THICKNESS
• 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: 21027279
• Report Number: 0001822565-2024-04072
• Device Sequence Number: 8310720
• Product Code: JWH
• UDI-Device Identifier: 00889024556799
• UDI-Public: (01)00889024556799(17)300731(10)64802575
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42556605810
• Device Lot Number: 64802575
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 01/23/2025; 05/22/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/18/2025; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 79 KG