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 |