N
Patient 1
THE EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES (IN FRANCE) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET WITHIN THE UNITED STATES.
MAUDE MDR 9859065
- MDR report key
- 9859065
- Report number
- 3009532798-2020-19252
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-04-29
- Date received
- 2020-03-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. CEDRIC JOLY
- Address
- 1663 RUE DE MAJORNAS VIRIAT, 01440 FR
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HUMELOCK II | SHOULDER PROTHESIS | FX SOLUTIONS | KWT | 311-0312 | J124 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-20 | 0 | 1. H; 2. R |
Event Narratives#
D
Patient 1
REVISION SURGERY DUE TO A CUFF TEAR OCCURRED (B)(6) 2019. CEMENTED HUMERAL STEM AND CENTERED HEAD WERE REMOVED AND REPLACED BY CEMENTED HUMERAL STEM, GLENOID BASEPLATE, GLENOSPHERE AND HUMERAL CUP. PRIMARY SURGERY OCCURRED IN 2018 (EXACT DATE UNAVAILABLE).