FDA Adverse Event
Malfunction
Summary report: N
ANTHOLOGY INSERTER ANT SOFT
MDR report key: 10663093
·
Received October 12, 2020
Report
- Report Number
- 1020279-2020-05333
- Event Type
- Malfunction
- Date Received
- October 12, 2020
- Date of Event
- September 16, 2020
- Report Date
- December 5, 2020
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- LZO
- UDI-DI
- 03596010553409
- PMA / PMN Number
- K113789
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION RECEIVED BY THE REPORTER HAS IDENTIFIED THAT THIS EVENT HAS BEEN ALREADY REPORTED UNDER 1020279-2020-05165 (REF (B)(4)). THE NEW INFORMATION CONFIRMS THAT THIS IS A DUPLICATE COMPLAINT, THEREFORE, IF FURTHER DETAILS ARE PROVIDED IN FUTURE CONFIRMING THE OPPOSITE, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT WILL BE SUBMITTED OUTLINING BOTH EVENTS DETAILS AND OUR INVESTIGATIONS PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING SURGERY. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED (INSIDE OR OUTSIDE THE PATIENT). IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO PATIENT INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1126847 | ANTHOLOGY INSERTER ANT SOFT | PROSTHESES, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT | LZO | SMITH & NEPHEW, INC. | 71365721 | N/A | 03596010553409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |