MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT HIGH FLEX PRECOAT RIGHT MEDIAL/LEFT LATERAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377)

Event Date 08/28/2023

Event Type  Injury  

Event Description

It was reported that the patient was revised for pain, wear, implant fracture, osteolysis approximately 17 years 8 months post implantation.Surgeon discovered that the femoral component of the knee was fractured during revision.No additional information was provided.

Manufacturer Narrative

(b)(4).G2: canada.The product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 00584202408 articular surface size 4 8 mm ht lot# 60241017.Additional associated products: 00584200402 tibial component precoat right medial/left lateral size 4 lot# unk.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  h6-component code- suggested code: mechanical (04) - femur.Visual examination of the returned product found that the femoral was fractured.Sem was performed and fatigue fracture was observed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.The complaint was confirmed by the device being returned.The osteolysis and pain could not be confirmed by the information provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: FEMORAL COMPONENT HIGH FLEX PRECOAT RIGHT MEDIAL/LEFT LATERAL
• Type of Device: 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: 17764945
• MDR Text Key: 323615208
• Report Number: 0001822565-2023-02541
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00584201502
• Device Lot Number: 60169212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2004
• 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 Sex: Prefer Not To Disclose