FDA Adverse Event Injury Summary report: N

AESCULAT COLUMBUS

MDR report key: 11398618 · Received March 1, 2021

Report

Report Number: MW5099720
Event Type: Injury
Date Received: March 1, 2021
Date of Event: January 1, 2019
Report Date: March 1, 2021
Manufacturer: AESCULAP IMPLANT SYSTEMS, LLC
Product Code: JWH
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: WA, US
Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

PT CALLED TO REPORT AN ADVERSE EVENT INVOLVING HER AESCULAP LEFT KNEE IMPLANT. PATIENT STATED THAT SHE HAD THIS KNEE IMPLANTED IN 2018 AND NOTICED IN 2019 SHE BEGAN HAVING SEVERE PAIN. PATIENT STATED THAT HER DOCTOR DID A BONE SCAN WHICH SHOWED THE IMPLANT HAS LIFTED AND BECOME LOOSE. PATIENT STATED HER DOCTOR TOLD HER THE IMPLANT WILL NEED TO COME OUT. PATIENT STATED SHE WOULD BE CONTACTING MANUFACTURER TO ASK ABOUT POSSIBLE RECALL OF HER DEVICE MODEL NUMBER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot
293003	AESCULAT COLUMBUS	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	AESCULAP IMPLANT SYSTEMS, LLC	NR074K	52345948
293004	AESCULAT COLUMBUS CERAMIC COATED 70MM X 49MM T2 + ZE3	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	AESCULAP IMPLANT SYSTEMS, LLC	NR0742	52360025
293005	TIBIA TRAY CEMENTED 19X92MM OFFSET TIBIA STEM	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	AESCULAP IMPLANT SYSTEMS, LLC
293006	RETAINER 3 - PEG PATELLA	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	AESCULAP IMPLANT SYSTEMS, LLC
293007	A 20MM T2 + HIGH CONSTRAINED POLY	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	AESCULAP IMPLANT SYSTEMS, LLC

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Other