MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Joint Laxity (4526); Insufficient Information (4580)

Event Date 11/08/2022

Event Type  Injury  

Event Description

It was reported that 17 years post implantation the patient underwent a second revision surgery due to soft tissue instability.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical devices: 00599404023 - articular surface with locking screw size green/e,f 23 mm height for use with femoral e,f - 63075777.00597206532 - all poly petella standard cemented size 32 mm diameter 8.5 mm thickness - 60206863.00599003602 - prc agmt block post sz f 10mm - 53912200.00599003610 - distal femoral augment block precoat may be used with posterior and/or anterior blocks size f 5 mm augment with screw - 60172170.00599003610 - distal femoral augment block precoat may be used with posterior and/or anterior blocks size f 5 mm augment with screw - 60246727.00598800500 - stemmed tibial component precoat a/p wedged for cemented use only size 5 - 60183809.3025-020 - cmw 2 gentamicin - f364x20 00598801012 - stem extension straight 12mm dia x 100mm length(combined length 145mm) - 60223183.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.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: 0001822565-2022-03330.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: mechanical (g04) - femur.Visual examination of the provided pictures identified a femoral and articular surface implant with foreign material covering the implants.No other definitive statements can be made.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no identified soft tissue abnormality; overall fit and alignment as well as bone quality appears normal.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: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F RIGHT
• 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: 15920434
• MDR Text Key: 304871363
• Report Number: 0001822565-2022-03331
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 00599401692
• Device Lot Number: 60054783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2003
• 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): Required Intervention; Hospitalization
• Patient Sex: Male