MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-07-30 for GMK SPHERE FLEX TIBIAL INSERT SIZE 3 LEFT 10MM 02.12.0310FL manufactured by Medacta International Sa.
[21245131]
Surgeon retrieved patient to theatre for suspected infection. Surgeon was to wash out the knee and perform a liner exchange. In attempting to remove the liner the surgeon did not remove the screw and subsequently the tibial tray was explanted with the liner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006639916-2014-00099 |
| MDR Report Key | 4218053 |
| Report Source | 99 |
| Date Received | 2014-07-30 |
| Date of Report | 2014-07-30 |
| Date of Event | 2014-07-09 |
| Date Facility Aware | 2014-07-15 |
| Report Date | 2014-07-30 |
| Date Reported to FDA | 2014-07-30 |
| Date Reported to Mfgr | 2014-07-30 |
| Date Added to Maude | 2014-11-03 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GMK SPHERE FLEX TIBIAL INSERT SIZE 3 LEFT 10MM |
| Generic Name | KNEE FIXED PE TIBIAL INSERT |
| Product Code | KWH |
| Date Received | 2014-07-30 |
| Catalog Number | 02.12.0310FL |
| Lot Number | 140320 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDACTA INTERNATIONAL SA |
| Manufacturer Address | CASTEL SAN PIETRO SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-30 |