FDA Adverse Event Other Summary report: N

DEPUY SIGMA UKA PARTIAL KNEE BEARING

MDR report key: 17239369 · Received June 29, 2023

Report

Report Number
MW5119019
Event Type
Other
Date Received
June 29, 2023
Manufacturer
DEPUY ORTHOPAEDICS, INC.
Product Code
JWH
Report Source
Voluntary report
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

PRODUCT: DEPUY SIGMA UKA PARTIAL KNEE BEARING (MEDICAL DEVICE FAILED TWICE). ON 6/13/23, COMPLAINT RECEIVED FROM (B)(6) EXCERPTED: "COMPLAINANT STATED THE SURGERIES OCCURRED AT (B)(6) WHICH DR. (B)(6) OPERATED. COMPLAINANT REPORTED HE HAD ONE PARTIAL KNEE SURGERY AND A SECOND ONE THAT WAS AN EMERGENCY REVISION OF THE FIRST SURGERY. COMPLAINANT STATED ONE OF THE KNEE RECONSTRUCTIONS FAILED IN (B)(6) 2020 WHILE HE WAS CLIMBING STAIRS AT A STATE WRESTLING TOURNAMENT. COMPLAINANT STATED THE POLYURETHANE CAME OUT OF PLACE. COMPLAINANT STATED HE HAS A PARTIAL KNEE REPLACEMENT CONDUCTED TO SAVE THE KNEE REPLACEMENT. WHEN THE KNEE REPLACEMENT FAILED A SECOND TIME, HIS DOCTOR RECOMMENDED HE OBTAIN A SECOND OPINION OR OBTAIN ANOTHER SECOND FULL KNEE REPLACEMENT. COMPLAINANT STATED HE OBTAINED A SECOND OPINION FROM DR. (B)(6). DR. (B)(6)INFORMED HIM THAT HE WOULD NOT PERFORM A KNEE REPLACEMENT SURGERY AFTER ANOTHER DOCTOR HAD PREVIOUSLY CONDUCTED SURGERY THE FIRST TIME. DR. (B)(6) INFORMED THE COMPLAINANT HE WOULD PERFORM THE FULL KNEE REPLACEMENT SURGERY WITH THE ASSISTANCE BY DR. (B)(6)." THE COMPLAINANT STATED ONE OF THE KNEE RECONSTRUCTIONS FAILED IN (B)(6) 2020 WHILE HE WAS CLIMBING STAIRS AT A STATE WRESTLING TOURNAMENT. COMPLAINANT STATED THE POLYURETHANE CAME OUT OF PLACE. THE PATIENT IS STATUS-POST-RIGHT PARTIAL KNEE REPLACEMENT REVISION PERFORMED ON (B)(6) 2019 AND A RIGHT PARTIAL KNEE REPLACEMENT PERFORMED ON (B)(6) 2018. 66 YR. OLD MALE. REFERENCE REPORT: MW5119018.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2039633 DEPUY SIGMA UKA PARTIAL KNEE BEARING PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH DEPUY ORTHOPAEDICS, INC. H54815

Patients

Seq Age Sex Outcome Treatment
1 Male