MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Subluxation (4525); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: (b)(6).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs.141210 biomet ilok pri tib tray 59mm lot# 716390.Mdr: 0001825034-2023-02273.Unk femoral implant lot# unk.Mdr: 0001825034-2023-02275.Journal artical reference: the importance of selecting a cruciate-retaining total knee prosthesis for a patient with a large phsyiological posterior tibial slope-a case report.Journal of surgical case reports, 2022, 12, 1¿5.Https://doi.Org/10.1093/jscr/rjac584.

Event Description

It was reported through a case study journal article that a patient underwent a primary right total knee arthroplasty due to osteoarthritis on an unknown date.Subsequently, the patient presented with worsening pain, varus instability, and limited range of motion.Ten years after the initial surgery, the patient was revised.During the revision, metallosis was found with subluxation and wear of the femoral component, poly wear, and fracture of the posteromedial portion of the tibial component.The initial cruciate-retaining total knee was replaced with a constrained condylar knee system without further complications upon follow up.

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.  visual examination of the provided pictures identified the tibial plate is fractured and the articular surface shows heavy wear.As the products were not returned, further evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Insufficient information provided to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient presented with worsening pain and varus instability, rom 0-1008; radiographs showed posterior subluxation of the femoral component 10 years postop; during revision, metallosis found throughout the joint, wear of the medial femoral component and poly wear noted.Complaint is confirmed with the provided pictures and medical records.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: UNK ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17844351
• MDR Text Key: 324600395
• Report Number: 0001825034-2023-02276
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian