MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-03 for RESTORATION ADM X3 INS 28/48 1236-2-848 manufactured by Stryker Orthopaedics-mahwah.
| Report Number | 0002249697-2020-00015 |
| MDR Report Key | 9546258 |
| Report Source | CONSUMER |
| Date Received | 2020-01-03 |
| Date of Report | 2020-03-18 |
| Date of Event | 2018-03-23 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2017-05-13 |
| Date Added to Maude | 2020-01-03 |
| 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-CORK |
| Manufacturer Street | IDA INDUSTRIAL ESTATE |
| Manufacturer City | CARRIGTWOHILL NJ NA |
| Manufacturer Country | IE |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESTORATION ADM X3 INS 28/48 |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU |
| Product Code | MEH |
| Date Received | 2020-01-03 |
| Catalog Number | 1236-2-848 |
| Lot Number | 59797801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-03 |