MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for SMARTSET GHV GENTAMICIN 40G 5450-35-500 545035500 manufactured by Depuy Cmw - 9610921.
[188899297]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188899298]
Revision of knee components due to loose tibia. Attune tibia was implanted in 2016 and was removed by hand with no resistance or cement fixation. Patient requested to have revised implants returned to their possession. Was surgery delayed due to the reported event? --> no, was procedure successfully completed? --> yes, were fragments generated? --> no, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences --> no, was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown, (b)(4). Device property of -->none, device in possession of -->patient. By checking this box i certify that all information that are known/available has been disclosed. If any new information will be made available, the additional information will be submitted through cst. --> true.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09506 |
| MDR Report Key | 9890712 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY CMW - 9610921 |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL FY4 4QQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | FY4 4QQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTSET GHV GENTAMICIN 40G |
| Generic Name | BONE CEMENT : BONE CEMENT |
| Product Code | LOD |
| Date Received | 2020-03-27 |
| Model Number | 5450-35-500 |
| Catalog Number | 545035500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY CMW - 9610921 |
| Manufacturer Address | CORNFORD RD BLACKPOOL FY4 4QQ UK FY4 4QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |