FDA Adverse Event
Injury
Summary report: N
UNKNOWN JOURNEY II BCS KNEE INSERT
MDR report key: 18888249
·
Received March 12, 2024
Report
- Report Number
- 1020279-2024-00520
- Event Type
- Injury
- Date Received
- March 12, 2024
- Date of Event
- February 20, 2024
- Report Date
- March 12, 2024
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H10: INTERNAL COMPLAINT REFERENCE: CASE (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOW DATE, THE PATIENT EXPERIENCED SUDDEN INSTABILITY IN THE KNEE. UPON EXAMINATION, IT WAS NOTICED THAT THE POST HAD FRACTURED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. THE 15MM LEFT 5-6 BCS POLY WAS REMOVED AND A NEW 18MM LEFT 5-6 JLL CR DISHED POLY WAS IMPLANTED. PATIENT WAS STABLE ON THE TABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724273 | UNKNOWN JOURNEY II BCS KNEE INSERT | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | SMITH & NEPHEW, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O |