MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-03-16 for UNKNOWN DEPUY GMV CEMENT UNK-CEMENT/CEM ACCESORY manufactured by Depuy Cmw 9610921.
[70094411]
Follow-up with the complainant has been conducted for the catalog number and lot number and this information is unavailable. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[70094412]
Patient was revised to address pain and tibial loosening. Loosening occurred at the cement/implant interface. Cement manufactured by depuy.
Patient Sequence No: 1, Text Type: D, B5
[73862538]
No device associated with this report was received for examination. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2017-14782 |
| MDR Report Key | 6409415 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-03-16 |
| Date of Report | 2017-03-07 |
| Date of Event | 2017-03-07 |
| Date Mfgr Received | 2017-03-30 |
| Date Added to Maude | 2017-03-16 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY CMW 9610921 |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL, LANCASHIRE 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 | UNKNOWN DEPUY GMV CEMENT |
| Generic Name | CEMENT / CEMENT ACCESSORY |
| Product Code | JDY |
| Date Received | 2017-03-16 |
| Catalog Number | UNK-CEMENT/CEM ACCESORY |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY CMW 9610921 |
| Manufacturer Address | CORNFORD RD BLACKPOOL, LANCASHIRE FY4 4QQ UK FY4 4QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-16 |