FDA Adverse Event
Injury
Summary report: N
MOTO PARTIAL KNEE 02.18.003LM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM
MDR report key: 14788250
·
Received June 23, 2022
Report
- Report Number
- 3005180920-2022-00479
- Event Type
- Injury
- Date Received
- June 23, 2022
- Date of Event
- May 24, 2022
- Report Date
- June 23, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- HSX
- UDI-DI
- 07630030895579
- PMA / PMN Number
- K162084
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 25-MAY-2022 LOT 182108: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2018. EXPIRATION DATE: 2023-MAY-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS ALMOST 3 YEARS AND 7 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329241 | MOTO PARTIAL KNEE 02.18.003LM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM | KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED | HSX | MEDACTA INTERNATIONAL SA | 02.18.003LM | 182108 | 07630030895579 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |