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 2020-03-12 for SYSTEM ONE BIPOLAR 6074-4922 manufactured by Stryker Orthopaedics-mahwah.
[188630191]
An investigation is being performed in an attempt to identify the cause of the event. Should additional information become available it will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[188630192]
The patient underwent bipolar hip arthroplasty in 1996. The bipolar cup was broken, and dislocation occurred. Therefore, the bipolar cup and the inner head were removed and tha was performed on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00516 |
| MDR Report Key | 9824321 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-12 |
| 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 | MRS. DIANA ROGERS |
| Manufacturer Street | 210 CENTENNIAL AVENUE CENTENNIAL PARK, ELSTREE |
| Manufacturer City | BOREHAMWOOD WD6 3SJ |
| Manufacturer Country | GB |
| Manufacturer Postal | WD6 3SJ |
| Manufacturer Phone | 2082386500 |
| 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 | SYSTEM ONE BIPOLAR |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED |
| Product Code | LWJ |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | 6074-4922 |
| Lot Number | 94H604 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-12 |