MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-30 for SMARTSET GHV GENTAMICIN 40G 5450-35-500 545035500 manufactured by Depuy Orthopaedics Inc Us.
[186184732]
(b)(4). Initial reporter occupation: lawyer. 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
[186184733]
Medical records received 17 june 2019 and were reviewed 24 october 2019 for mdr reportability. On (b)(6) 2016, the patient underwent total right knee arthroplasty revision due to arthrofibrosis status post right total knee arthroplasty with unknown components, with debridement. The surgeon the indicated the implants were well-fixed and aligned though revised due to tight flexion despite debridement of scar tissue. The patella was noted to be intact and not revised. The surgeon reported no intraoperative complications. The patient was implanted the patient was implanted with depuy knee system and depuy bone cement products. On (b)(6) 2018, the patient underwent a right knee revision due to loosening of the tibial component, stiffening, and pain. The surgeon reported the tibial component appeared to be well-fixed but was able to disrupt the component after a few blows. He noted a well-fixed femoral component though was revised. The surgeon reported the removal of scar tissue surrounding the patella, and it was not revised. The patient was implanted with depuy knee system and smartset cement x 2. Doi: (b)(6) 2016, dor: (b)(6) 2018, (rt knee).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09617 |
| MDR Report Key | 9900103 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-12 |
| Date of Event | 2018-03-05 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2015-06-16 |
| Date Added to Maude | 2020-03-30 |
| 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 | 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 | 2020-03-30 |
| Model Number | 5450-35-500 |
| Catalog Number | 545035500 |
| Lot Number | 8077683 |
| Device Expiration Date | 2017-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |