MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-01-09 for CUSTOM RIGHT ULNAR COMP C-HM29-6-400 manufactured by Stryker Orthopaedics Mahwah.
[16642849]
It was reported that the patient broke the ulnar component while lifting a lawnmower. X-rays showed a broken ulnar stem. Revision was required and the surgeon implanted the new customer ulnar component in 2007.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249697-2008-00005 |
| MDR Report Key | 978181 |
| Report Source | 07 |
| Date Received | 2008-01-09 |
| Date of Report | 2007-12-11 |
| Date of Event | 2007-12-11 |
| Date Mfgr Received | 2007-12-11 |
| Date Added to Maude | 2008-01-17 |
| 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 | JANICE PEVIDE |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM RIGHT ULNAR COMP |
| Generic Name | IMPLANT |
| Product Code | KXE |
| Date Received | 2008-01-09 |
| Model Number | NA |
| Catalog Number | C-HM29-6-400 |
| Lot Number | UNK |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 947600 |
| Manufacturer | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Address | MAHWAH NJ 07430 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-09 |