MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ASCENT PRI INLK FMRL MED LT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs.141224 biomet cc i-beam tray lot# 712590.141225 biomet cc i-beam tray lot# 754160.Mdr: 0001825034-2021-01947.11-150842 bmet arcom ap pat 3pst lot# 800090.11-150842 bmet arcom ap pat 3pst lot# 741540.Mdr: 0001825034-2021-01948.179321 ascent pri lip brg lot# 685050.179331 ascent pri lip brg lot# 624390.Mdr: 0001825034-2021-01949.

Event Description

It was reported the patient underwent a left knee procedure on an unknown date.Subsequently, the patient was revised due to loosening.No additional information according to per.

Manufacturer Narrative

No devices or photographs were received; therefore the condition of the components is unknown.Review of the device history records identified no related deviations or anomalies during manufacturing.No compatibility issues were noted.Medical records were not provided.This complaint cannot be confirmed.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

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

• Brand Name: ASCENT PRI INLK FMRL MED LT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12099633
• MDR Text Key: 259396151
• Report Number: 0001825034-2021-01946
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171054
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2012
• Device Model Number: N/A
• Device Catalogue Number: 179013
• Device Lot Number: 771170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2002
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 83 KG