MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT LEFT MEDIAL/RIGHT LATERAL SIZE 5; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544)

Event Date 07/28/2022

Event Type  Injury  

Event Description

It was reported by the patient that they underwent an initial left partial knee arthroplasty.Subsequently, the patient was revised approximately 7 years later due to pain, a limp, and an implant fracture and loosening was also noted on scans.During the revision, both the tibial and femoral components were found loose with the femoral component fractured.The components were removed along with hypertrophic scarring without complications.A competitor total knee was then implanted.Attempts have been made and all available information has been provided.

Manufacturer Narrative

(b)(4).D10: 00584201601 - femoral component high flex precoat for cemented use only left medial/right lateral - 62663561, 00584209508 - articular surface size 5 8 mm height femoral size a, b, c, d, e, f, g - 62880761, 00619201001 - stryker simplex speedset cement - dev009.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03699.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: persistent left knee pain, bone scan concerning for loosening, x-rays showed fracture of the femoral component, tibial component grossly loose, severe pfj degenerative changes, mild degenerative changes in the lateral joint, hypertrophic scarring and synovial tissue removed, underwent additional rehab.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: TIBIAL COMPONENT PRECOAT LEFT MEDIAL/RIGHT LATERAL SIZE 5
• 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: 18364456
• MDR Text Key: 330996615
• Report Number: 0001822565-2023-03700
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00584200501
• Device Lot Number: 62880941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: White