MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2006-05-15 for S-ROM HEAD FEMORAL COCR 28+3 875953 manufactured by Depuy Internaltional, Ltd..
[448280]
The patient was revised due to chronic dislocation, fracture of the greater trochanter, osteolysis was present. The patent has depuy stem and head with competitor's cup and liner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2006-01562 |
| MDR Report Key | 715863 |
| Report Source | 05,08 |
| Date Received | 2006-05-15 |
| Date of Report | 2006-05-11 |
| Date of Event | 2006-05-11 |
| Date Facility Aware | 2006-05-11 |
| Report Date | 2006-05-11 |
| Date Mfgr Received | 2006-05-11 |
| Device Manufacturer Date | 2003-11-01 |
| Date Added to Maude | 2006-05-19 |
| 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 | 3 |
| Manufacturer Contact | GINNY STAMBERGER, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY INTERNATIONAL, LTD. |
| Manufacturer Street | ST. ANTHONY'S ROAD |
| Manufacturer City | LEEDS LS118DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8DT |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S-ROM HEAD FEMORAL COCR 28+3 |
| Generic Name | TOTAL HIP PROSTHESIS |
| Product Code | OQI |
| Date Received | 2006-05-15 |
| Model Number | NA |
| Catalog Number | 875953 |
| Lot Number | 1132028 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 704935 |
| Manufacturer | DEPUY INTERNALTIONAL, LTD. |
| Manufacturer Address | ST ANTHONY'S RD LEEDS UK LS11 8DT |
| Baseline Brand Name | S-ROM HEAD FEMORAL COCR 28+3 |
| Baseline Generic Name | FEMORAL HEAD |
| Baseline Model No | NA |
| Baseline Catalog No | 875953 |
| Baseline ID | NA |
| Baseline Device Family | S-ROM HEAD FEMORAL COCR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K920317 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-05-15 |