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 2020-03-19 for UNKNOWN DISTAL FEMORAL REPLACEMENT UNK_STM manufactured by Stanmore Implants Worldwide.
[188840550]
It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. The following devices were also listed in this report: smiles knee circlip mk2; cat# smcic01; lot# b14331, smiles knee bushes standard; cat# smbsh02; lot# b9353, smiles knee bumpers standard; cat# smbpr02; lot# b11272. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[188840551]
The sales representative reported that: "this is a revision of a distal femoral replacement implanted in 2017 (pin (b)(4)). In 2017 the surgeon decided to do a? Simple? Distal femoral replacement with no growing mechanism for the patient, as the prognosis for this patient was not good. Now the patient's health has improved the surgeon would like to revise the implant to a distal femoral jts implant to compensate the leg length discrepancy. The tibial component will remain in situ.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004105610-2020-00067 |
| MDR Report Key | 9853177 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-19 |
| 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. COLLIN NEITZEL |
| 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 | UNKNOWN DISTAL FEMORAL REPLACEMENT |
| Generic Name | PROSTHESIS, HIP, HEMI-, FEMORAL, METAL |
| Product Code | KWL |
| Date Received | 2020-03-19 |
| Catalog Number | UNK_STM |
| Lot Number | PIN 20398 |
| Device Expiration Date | 2017-06-30 |
| 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 | 2020-03-19 |