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 2020-03-18 for TOTAL KNEE REPLACEMENT UNK_STM manufactured by Stanmore Implants Worldwide.
[188839925]
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. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[188839926]
The sales representative reported "the surgeon had some difficulties with this case and was not so happy... As far as i know he ended up resecting more bone as planned. This ended up in a situation of stem being too long and needed to be shortened in the operating room. I understood the original planned resection level was not big enough for the hinge mechanism causing this issue. There was a surgical delay: between 60 to 90 min. The sales rep also reported a periprosthetic fracture "after the additional resection on tibia he needed to ream more for the stem and the reamer made a hole in to tibial wall (perforated) which he was fixing with plating. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004105610-2020-00066 |
| MDR Report Key | 9848865 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-18 |
| 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 | 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 | TOTAL KNEE REPLACEMENT |
| Generic Name | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER |
| Product Code | KRO |
| Date Received | 2020-03-18 |
| Catalog Number | UNK_STM |
| Lot Number | PIN 22225 |
| 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. Other | 2020-03-18 |