MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1999-08-18 for CEMENTRALIZER 10.5 137638000 manufactured by Depuy Orthopaedics, Inc..
[159907]
During a total hip surgery; the cementralizer sheared off and the femoral component couldn't be seated. Surgeon had to remove the femoral component. The cementralizer was left in the pt. Some of the bone cement had already hardened. They did additional work to get a new femoral component and cementralizer put in. There was no pt injury; but a delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-1999-00115 |
| MDR Report Key | 236423 |
| Report Source | 05,07 |
| Date Received | 1999-08-18 |
| Date of Report | 1999-08-18 |
| Date of Event | 1999-07-19 |
| Date Facility Aware | 1999-07-21 |
| Report Date | 1999-08-18 |
| Date Mfgr Received | 1999-07-21 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 1999-08-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 10.5 |
| Generic Name | TOTAL HIP PROSTHESIS |
| Product Code | LTO |
| Date Received | 1999-08-18 |
| Model Number | NA |
| Catalog Number | 137638000 |
| Lot Number | S82JD1011 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 229120 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US |
| Baseline Brand Name | CEMENTRALIZER 10.5 |
| Baseline Generic Name | CEMENT SPACER |
| Baseline Model No | NA |
| Baseline Catalog No | 137638000 |
| Baseline ID | NA |
| Baseline Device Family | CEMENTRALIZERS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K871510 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-08-18 |