MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,07 report with the FDA on 2006-05-24 for HUMERAL STEM, 6MM AR-9100-06 manufactured by Arthrex, Inc..
[470188]
Patient was implanted the univers total shoulder in 03 as part of a revision of hemiarthroplasty from 1987. Recovery from procedure was uncomplicated and overall excelent. Surgeon reports fatigue, occasional soreness but tremendously better than preop. In 2005, patient developed pain in shoulder, as patient reached for an overhead item at work. Forward elevation degree reduced after the incident. Radiographs demonstrate rotation of head to an inferior offset, different than previous x-rays. A revision surgery was required. The stem was removed and replaced with a competitor's stem. Post operative course has been uneventful. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2006-00064 |
| MDR Report Key | 718135 |
| Report Source | 00,05,07 |
| Date Received | 2006-05-24 |
| Date of Report | 2006-05-22 |
| Date of Event | 2005-11-19 |
| Date Mfgr Received | 2006-04-24 |
| Date Added to Maude | 2006-05-25 |
| 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 Contact | IVETTE GALMEZ, SENIOR ANALYST |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMERAL STEM, 6MM |
| Generic Name | HUMERAL STEM, (3D TOTAL SHOULDER SYSTEM) |
| Product Code | KWJ |
| Date Received | 2006-05-24 |
| Returned To Mfg | 2006-04-01 |
| Model Number | NA |
| Catalog Number | AR-9100-06 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 707212 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | * NAPLES FL * US |
| Baseline Brand Name | HUMERAL STEM, 6 MM |
| Baseline Generic Name | HUMERAL STEM (3D TOTAL SHOULDER SYSTEM) |
| Baseline Catalog No | AR-9100-06 |
| Baseline Device Family | PROSTHESIS SHOULDER, SEMI CONSTRAINED METAL POLYMER CEMENTED |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K010124 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-24 |