MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-04-26 for ACETABULAR LINER UNK manufactured by Stryker Orthopaedics Mahwah.
[17369960]
The facility reported on behalf of the customer that the pt underwent a revision of acetabular left total hip replacement. It is reported that the hip was dislocated and the surgeon removed the head from the restoration stem and replaced the liner from the trident shell and inserted a constrained liner.
Patient Sequence No: 1, Text Type: D, B5
[17687923]
Mdr report # 2249697-2007-00039. Device not rec'd, no eval will be performed. If the device becomes available, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2249697-2007-00054 |
| MDR Report Key | 843413 |
| Report Source | 07 |
| Date Received | 2007-04-26 |
| Date of Report | 2007-03-30 |
| Date of Event | 2007-02-26 |
| Date Mfgr Received | 2007-03-30 |
| Date Added to Maude | 2007-05-03 |
| 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 | 0 |
| Manufacturer Contact | ROSE MINCIELI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACETABULAR LINER |
| Generic Name | IMPLANT |
| Product Code | KBW |
| Date Received | 2007-04-26 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 830531 |
| Manufacturer | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Address | * MAHWAH NJ 07430 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-26 |