MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-02-15 for CLP HIP 426-00-070 manufactured by Encore Medical, L.p..
[2522437]
Revision surgery - the pt fell and broke their femur. The product did not fail, however, it did need to be replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644408-2012-00072 |
| MDR Report Key | 2467761 |
| Report Source | 07 |
| Date Received | 2012-02-15 |
| Date of Report | 2012-01-29 |
| Date of Event | 2012-01-29 |
| Date Mfgr Received | 2012-01-29 |
| Device Manufacturer Date | 2011-04-13 |
| Date Added to Maude | 2012-07-30 |
| 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 | TEFFANY HUTTO |
| Manufacturer Street | 9800 METRIC BLVD. |
| Manufacturer City | AUSTIN TX 78758 |
| Manufacturer Country | US |
| Manufacturer Postal | 78758 |
| Manufacturer Phone | 5128346255 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLP HIP |
| Generic Name | STANDARD OFFSET STEM |
| Product Code | KWJ |
| Date Received | 2012-02-15 |
| Catalog Number | 426-00-070 |
| Lot Number | 142C1009 |
| Device Expiration Date | 2017-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENCORE MEDICAL, L.P. |
| Manufacturer Address | AUSTIN TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-02-15 |