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 PROXIMAL TIBIA JTS UNK_STM manufactured by Stanmore Implants Worldwide.
[184922350]
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. Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. Not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[184922351]
A patient specific prescription form was provided for the patient's right proximal tibia with the following information: indication/ diagnosis: limb length discrepancy. Reason for revision: limb length discrepancy, muscle contracture. Notes: save femoral component. The overall replacement should cover the extension (~200-220 mm). Additional information provided by the rep: "the patient has a pain during the knee extension and a muscle contracture. This is the reason the implant cannot be extended. The issue cannot be solved by shortening the implant, the surgeon wishes to replace this. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004105610-2020-00069 |
| MDR Report Key | 9859442 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2017-08-02 |
| 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. JOANN LAVATELLI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STANMORE IMPLANTS WORLDWIDE |
| Manufacturer Street | 210 CENTENNIAL AVENUE CENTENNIAL PARK, ELSTREE |
| Manufacturer City | BOREHAMWOOD WD6 3SJ |
| Manufacturer Country | GB |
| Manufacturer Postal Code | WD6 3SJ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROXIMAL TIBIA JTS |
| Generic Name | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER |
| Product Code | KRO |
| Date Received | 2020-03-20 |
| Catalog Number | UNK_STM |
| Lot Number | PIN 20850 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANMORE IMPLANTS WORLDWIDE |
| Manufacturer Address | 210 CENTENNIAL AVENUE CENTENNIAL PARK, ELSTREE BOREHAMWOOD WD6 3SJ GB WD6 3SJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-20 |