MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-30 for EXP ACETABULAR SHELL AND LINER SC3261-36MM +7 manufactured by Stelkast, Inc..
[16227325]
Patient dislocated in recovery. The surgeon's opinion is that he did not allow for enough anteversion - corrected with hooded liner. The original stem, head and liner were also replaced.
Patient Sequence No: 1, Text Type: D, B5
[16349094]
A review of the device history record for this device shows that no material property, mechanical, or dimensional discrepancies existed in this lot. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2530191-2015-00021 |
| MDR Report Key | 4954291 |
| Report Source | 07 |
| Date Received | 2015-07-30 |
| Date of Report | 2015-07-30 |
| Date of Event | 2015-07-02 |
| Date Mfgr Received | 2015-07-09 |
| Device Manufacturer Date | 2011-07-14 |
| Date Added to Maude | 2015-07-30 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 36MM COCR FEMORAL HEAD |
| Product Code | OQI |
| Date Received | 2015-07-30 |
| Model Number | SC3261-36MM +7 |
| Catalog Number | SC3261-36MM +7 |
| Lot Number | 26414-070611 |
| 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. Required No Informationntervention | 2015-07-30 |