MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-20 for TRIDENT 0 DEG CONSTRAINED INSERT 28G 690-00-28G manufactured by Stryker Orthopaedics-mahwah.
[184916317]
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[184916318]
Patient presented acutely with a dislocated hip. On x-ray it was evident that the inner bipolar outer femoral head had dislocated from the polyethylene liner portion of the trident 0 degree constrained liner. Patient was 3 weeks post op/implantation. Said had bent forward only a small degree to pick something up with her grasper and felt it pop out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00576 |
| MDR Report Key | 9860653 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-22 |
| Device Manufacturer Date | 2019-05-28 |
| Date Added to Maude | 2020-03-20 |
| 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. COLLIN NEITZEL |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIDENT 0 DEG CONSTRAINED INSERT 28G |
| Generic Name | PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER |
| Product Code | KWZ |
| Date Received | 2020-03-20 |
| Model Number | 690-00-28G |
| Catalog Number | 690-00-28G |
| Lot Number | R26H3J |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-20 |