MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2023-00321, 3007963827-2023-00322, 3007963827-2023-00323, 0002648920-2023-00285.D10-medical product: articular surface (mc) left 10 mm height, item# 42512100310, lot# 65106823.Femur cemented (cr) narrow left size 5, item# 42502005801, lot# 64957640.Tibia cemented 5 degree stemmed left size c, item# 42532006401, lot# 65032763.All-poly patella cemented 32 mm diameter, item# 42540200032, lot# 65029451.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.

Event Description

It was reported that a patient underwent a revision of all components approximately one year nine and a half months post implantation due to instability.Attempts to obtain additional information have been made; however, no more information is available.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned, and pictures provided were insufficient to complete visual and dimensional evaluations.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.The complaint is not confirmed.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: - mechanical (g04) - stem.

• Brand Name: STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH
• 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: 18277078
• MDR Text Key: 329856828
• Report Number: 0001822565-2023-03333
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024247734
• UDI-Public: (01)00889024247734(17)311005(10)65263755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• 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: 42557000114
• Device Lot Number: 65263755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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): Required Intervention; Hospitalization
• Patient Sex: Female