MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-11 for EXP ACETABULAR SHELL AND LINER SC3348-32MM +3.5 manufactured by Stelkast Inc..
[105136506]
An evaluation of the device cannot be performed as the device was not returned. There is no evidence to suggest that a device malfunction had occurred.
Patient Sequence No: 1, Text Type: N, H10
[105136508]
Patient presented for surgery for hip dislocation. Femoral head revised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530191-2018-00039 |
| MDR Report Key | 7420941 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2016-02-19 |
| Date Added to Maude | 2018-04-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN REYHER |
| Manufacturer Street | 200 HIDDEN VALLEY ROAD |
| Manufacturer City | MCMURRAY PA 15317 |
| Manufacturer Country | US |
| Manufacturer Postal | 15317 |
| Manufacturer Phone | 7249416368 |
| Manufacturer G1 | STELKAST INC. |
| Manufacturer Street | 200 HIDDEN VALLEY ROAD |
| Manufacturer City | MCMURRAY PA 15317 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15317 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXP ACETABULAR SHELL AND LINER |
| Generic Name | 32MM BIOLOX DELTA FEMORAL HEAD |
| Product Code | MAY |
| Date Received | 2018-04-11 |
| Model Number | SC3348-32MM +3.5 |
| Lot Number | 34981260219 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STELKAST INC. |
| Manufacturer Address | 200 HIDDEN VALLEY ROAD MCMURRAY PA 15317 US 15317 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-04-11 |