MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-24 for UNKNOWN 2047-XXXX(ALUMINA CERAMIC LINER) UNK_SHC manufactured by Stryker Orthopaedics-mahwah.
[32095717]
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[32095718]
This is from conference presentation in (b)(6). It was reported that there was confirmation of dislocation after the medical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-04045 |
| MDR Report Key | 5248544 |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-10 |
| Date of Event | 2015-10-30 |
| Date Mfgr Received | 2015-11-10 |
| Date Added to Maude | 2015-11-24 |
| 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. SANDRA SPOKANE |
| 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 NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN 2047-XXXX(ALUMINA CERAMIC LINER) |
| Generic Name | HIP IMPLANT |
| Product Code | LPF |
| Date Received | 2015-11-24 |
| Catalog Number | UNK_SHC |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| 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 | 2015-11-24 |