MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-05-06 for SILASTIC H.P.100 SWANSON WRIST JOINT IMPLANT WITH GROMMETS G4880204 manufactured by Dow Corning Corp..
[15684749]
Reporter alleges patient's implant broke.
Patient Sequence No: 1, Text Type: D, B5
[20710548]
The distal stem, more than 1/2 of the hinge midsection and the distal grommet were missing. Scratches probably from instruments used during the explantation surgery; whitish, flaky material, believed to be silicone debris that wore from the implant; not possible to unequivocally determine the cause of the complications, however, the morphology of the implant specimens indicate that implant destruction was caused by severe conditions of exposure while implanted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1816403-1997-00511 |
| MDR Report Key | 89637 |
| Report Source | 05 |
| Date Received | 1997-05-06 |
| Date of Report | 1997-03-07 |
| Date Mfgr Received | 1997-04-08 |
| Date Added to Maude | 1997-05-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILASTIC H.P.100 SWANSON WRIST JOINT IMPLANT WITH GROMMETS |
| Generic Name | WRIST JOINT IMPLANT |
| Product Code | KWM |
| Date Received | 1997-05-06 |
| Model Number | NA |
| Catalog Number | G4880204 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | OTHER |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 88618 |
| Manufacturer | DOW CORNING CORP. |
| Manufacturer Address | 2200 WEST SALZBURG ROAD AUBURN MI 48611 US |
| Baseline Brand Name | SILASTIC H.P.100 SWANSON WRIST JOINT IMPLANT WITH GROMMETS |
| Baseline Generic Name | WRIST JOINT IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | G4880204 |
| Baseline ID | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-05-06 |