FDA Adverse Event
Injury
Summary report: N
HUMELOCK II CEMENTLESS
MDR report key: 11892152
·
Received May 27, 2021
Report
- Report Number
- 3009532798-2021-00061
- Event Type
- Injury
- Date Received
- May 27, 2021
- Date of Event
- March 31, 2021
- Report Date
- May 17, 2021
- Manufacturer
- FX SOLUTIONS
- Product Code
- PHX
- UDI-DI
- 03701037301357
- PMA / PMN Number
- K150488
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THIS MDR HAS ALREADY BEEN SUBMITTED TO FDA BY THE US IMPORTER WITH REPORT NUMBER (B)(4).
Description of Event or Problem · 1
PATIENT REVISED ON (B)(6) 2021 APPROXIMATELY 6 WEEKS AFTER PRIMARY SURGERY. PATIENT SUFFERED PERIPROSTHETIC FRACTURE FROM FALL, WHICH LED TO DISLOCATION. SURGEON EXPLANTED TWO CORTICAL SCREWS AND A 135/145 36/+3 STANDARD HUMERAL CUP, AND THEN IMPLANTED 2 NEW CORTICAL SCREWS, A 36/+9 STABILITY HUMERAL CUP, AND A 135/145 REVERSED ADAPTER FOR AN EXTRA +9MM OF SPACING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 788570 | HUMELOCK II CEMENTLESS | REVERSED SHOULDER PROSTHESIS | PHX | FX SOLUTIONS | DIAMETER 36+3 | M3157 | 03701037301357 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |