MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-06-20 for UNIVERSAL TOTAL WRIST (UTW) 16-5000 manufactured by Kinetikos Medical, Inc..
[492915]
In 2006, kinetikos medical, inc. , was informed of the explant and replacement of a utw carpal plate implant owing to pain associated with dislocation. The explanted component was returned to kmi for evaluation 8 days later.
Patient Sequence No: 1, Text Type: D, B5
[7780939]
The original implant surgery was performed in 2002 to redness a failed, unrelated procedure (proximal row carpectomy following kienbocks disease) at which time a size small +1 carpal poly component was used. In 2004 a revision was performed to address an ulnar utw 20mm bone screw determined to be too long, causing cmc 5 interference (15mm length screws were not available at the time of the original utw implant). The pt thereafter began an aggressive athletic training program (not therapy) which eventually resulted in carpal poly / radial component dislocation. Conservative treatment proved ineffective. A second revision was performed in 2006, this time using a +2 size carpal poly. The explanted original +1 carpal poly was forwarded to kmi for evaluation, which was received and evaluated the following month. It was readily apparent from the returned implant that the pt had experienced a severe dislocation as evidence by the damage to the articulating area of the carpel poly (deep, distinct wear pattern indicating misalignment infringement of the corresponding radial component). The device history file of the carpel poly part lot could not be research, as the 'old' model utw carpal poly components do not have lot number identification etchings. The nature of the damage observed did not suggest component defects. Following the latest revision the pt was placed in a plaster cast, the new wrist implant was reported as stable, and her prognosis is very good. Given the (effective) change to a +2 size, it would appear that the original choice of carpal poly size 1+ was less than optimum for this case, as the impingement / dislocation experienced is one possible outcome if a carpal poly component is selected that is too small for the pts particular needs, and in this case was further exacerbated by the pts lifestyle / activity level.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028840-2006-00010 |
| MDR Report Key | 728032 |
| Report Source | 07 |
| Date Received | 2006-06-20 |
| Date of Report | 2006-06-16 |
| Date of Event | 2006-05-24 |
| Date Mfgr Received | 2006-06-14 |
| Date Added to Maude | 2006-06-23 |
| 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 | 0 |
| Manufacturer Street | 6005 HIDDEN VALLEY RD |
| Manufacturer City | CALSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal | 92011 |
| Manufacturer Phone | 7604481706 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL TOTAL WRIST (UTW) |
| Generic Name | ORTHOPEDIC WRIST IMPLANT |
| Product Code | KWM |
| Date Received | 2006-06-20 |
| Returned To Mfg | 2006-06-14 |
| Model Number | 16-5000 |
| Catalog Number | 16-5000 |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 716310 |
| Manufacturer | KINETIKOS MEDICAL, INC. |
| Manufacturer Address | * CARLSBAD CA 92011 US |
| Baseline Brand Name | UNIVERSAL TOTAL WRIST (UTW) |
| Baseline Generic Name | ORTHOPEDIC WRIST IMPLANT |
| Baseline Model No | 16-5000 |
| Baseline Catalog No | 16-5000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-20 |