MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC I-BEAM TRAY 67MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices -vanguard cr interlok fem - lt 65 catalog #: 183028 lot #: j6668151; vngd cr tib brg 10x63/67 catalog #: 183420 lot #: 767860.The complainant has indicated that 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.Investigation incomplete.

Event Description

It was reported the patient underwent an initial left uni-condylar knee replacement.The patient began to develop pain and decreased range of motion and despite more conservative interventions was revised due to a total knee due to microscopic loosening.The patient continued to have pain and underwent revision of the poly which was noted to have some wear medially and had patellar resurfacing due to degenerative joint disease.Attempts have been made, but there is no additional information at this time.

Event Description

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: BIOMET CC I-BEAM TRAY 67MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12143660
• MDR Text Key: 260765429
• Report Number: 0001825034-2021-02035
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: N/A
• Device Catalogue Number: 141222
• Device Lot Number: J6498198
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 83