MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RS SIDE EXP DSTL FMRL LT 24CM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a left knee revision approximately six years and eight months postoperatively due to collapse of the expandable femoral.

Manufacturer Narrative

Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001825034-2019-04093.

Event Description

Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001825034-2019-04093.

• Brand Name: RS SIDE EXP DSTL FMRL LT 24CM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11617038
• MDR Text Key: 243914979
• Report Number: 0001825034-2021-01003
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K140509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: CP114840
• Device Lot Number: 489210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Weight: 68