FDA Adverse Event
Other
Summary report: N
SROM NCK TRL 36MM STD +6 LAT
MDR report key: 1885393
·
Received October 22, 2010
Report
- Report Number
- 1818910-2010-07354
- Event Type
- Other
- Date Received
- October 22, 2010
- Date of Event
- September 24, 2010
- Report Date
- February 27, 2026
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE PT'S GREATER TROCHANTER WAS FRACTURED WHILE TRIALING. THIS WAS AN SROM SURGERY WITH A 16X11 TRIAL STEM AND 36+6 NECK TRIAL. THE NECK TRIAL IS LARGER THAN THE ACTUAL IMPLANT IN THE LATERAL SHOULDER REGION. THE SURGEON SAYS THE FRACTURE WOULD NOT HAVE HAPPENED IF THE TRIAL WAS THE SAME SIZE AS THE ACTUAL IMPLANT. THIS CAUSED A ONE (1) HOUR SURGICAL DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SROM NCK TRL 36MM STD +6 LAT | 87LXH | LXH | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |