MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-09-24 for UNKNOWN DEPUY SMARTSET HV CEMENT manufactured by Depuy Cmw.
[2971517]
Patient was revised to address loosening of the tibial tray at the cement/implant interface and pain. Depuy cement was used at the time of original implantation. It was noted that only the top of the tibial tray had been cemented. (left knee).
Patient Sequence No: 1, Text Type: D, B5
[10174827]
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
[10306739]
The devices associated with this report were not returned. Review of the device history records and/or a complaint database search was not possible as the lot codes required were not provided. Requests for additional investigational inputs were made in accordance with wi-7915 appendix a; rev. C. No additional information was obtained. The investigation could not draw any conclusions regarding the reported event with the information available. Based on the inability to identify a root cause, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2012-20147 |
| MDR Report Key | 2755614 |
| Report Source | 05,08 |
| Date Received | 2012-09-24 |
| Date of Report | 2012-09-19 |
| Date of Event | 2012-09-19 |
| Date Mfgr Received | 2012-09-19 |
| Date Added to Maude | 2012-09-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONALD DION JR. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer G1 | DEPUY CMW |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DEPUY SMARTSET HV CEMENT |
| Generic Name | BONE CEMENT |
| Product Code | JDY |
| Date Received | 2012-09-24 |
| Catalog Number | UNK |
| 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 |
| Manufacturer Address | CORNFORD RD BLACKPOOL UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-24 |