FDA Adverse Event
Injury
Summary report: N
SHADDING SZ25 LT TRIFLANGE
MDR report key: 3071490
·
Received April 22, 2013
Report
- Report Number
- 0001825034-2013-01090
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- March 11, 2013
- Report Date
- March 26, 2013
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- LPH
- PMA / PMN Number
- PK983035
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT HIP ARTHROPLASTY PROCEDURE UTILIZING A CUSTOM TRI-FLANGE ACETABULAR COMPONENT ON (B)(6) 2013. DURING THE PROCEDURE, THE TRI-FLANGE COMPONENT WOULD NOT FIT. A COMPETITOR ACETABULAR SHELL WAS USED TO COMPLETE THE PROCEDURE; HOWEVER, A TWO HOUR DELAY OCCURRED AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172693 | SHADDING SZ25 LT TRIFLANGE | PROSTHESIS, HIP | LPH | BIOMET ORTHOPEDICS | N/A | 453900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |