MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-06 for CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM SC3458-52 manufactured by Stelkast Inc..
[101641208]
An evaluation of the device cannot be performed as the device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[101641210]
Patient presented for hip surgery for unknown reason. During this surgery, the surgeon used a 36mm liner inserter to insert an acetabular liner into the shell. During impaction, it was stated that the liner would not seat properly. While extracting the liner with a hemostat, the surgeon noted that the locking ring detached from the acetabular shell. The locking ring was reinserted and using a 32mm liner inserter he was able to seat the original liner properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530191-2018-00030 |
| MDR Report Key | 7317834 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-03-06 |
| Date of Report | 2018-03-06 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-28 |
| Device Manufacturer Date | 2017-04-09 |
| Date Added to Maude | 2018-03-06 |
| 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 |
| 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 | CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM |
| Generic Name | CROSS OVER SHELL |
| Product Code | MAY |
| Date Received | 2018-03-06 |
| Model Number | SC3458-52 |
| Lot Number | 38853270409 |
| 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 | 2018-03-06 |