MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-25 for SMARTSET GHV GENTAMICIN 40G 5450-35-500 545035500 manufactured by Depuy Cmw - 9610921.
[186286671]
Product complaint # (b)(4). Initial reporter occupation: lawyer. (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
[186286672]
The patient received a left revision on (b)(6) 2019 to treat pain and instability. Upon entering the knee, the surgeon encountered and excised scar tissue. The tibial tray was grossly loose at the cement to implant interface. The femoral component was well-fixed but revised. The patella was well-fixed and retained. There was no reported product problem with the explanted tibial insert. The patient received depuy revision devices utilizing unknown cement. The procedure was completed without complications. Doi: (b)(6) 2016, dor: (insert) (b)(6) 2018, dor: (b)(6) 2019, left knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09231 |
| MDR Report Key | 9879898 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-05-21 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2016-05-06 |
| Date Added to Maude | 2020-03-25 |
| 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 | CMW MFG & MATERIAL WAREHOUSE |
| 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 | 2020-03-25 |
| Model Number | 5450-35-500 |
| Catalog Number | 545035500 |
| Lot Number | 8273834 |
| Device Expiration Date | 2018-02-28 |
| 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 | 2020-03-25 |