MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2002-10-09 for M/H INTERLOK (NTS) 11-104509 manufactured by Biomet, Inc..
[20195151]
Left total hip arthroplasty reportedly performed on an unknown date in 1991. Pt fell getting out of shower in 2002. Femoral stem fractured and was replaced in 2002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2002-00092 |
| MDR Report Key | 421350 |
| Report Source | 06,07 |
| Date Received | 2002-10-09 |
| Date of Report | 2002-10-09 |
| Date of Event | 2002-08-26 |
| Date Mfgr Received | 2002-09-09 |
| Device Manufacturer Date | 1991-02-01 |
| Date Added to Maude | 2002-10-15 |
| 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 | 0 |
| Manufacturer Contact | BETH ALBERT, AST |
| Manufacturer Street | PO BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1064/1069-5 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M/H INTERLOK (NTS) |
| Generic Name | PROSTHESIS, HIP, COMP |
| Product Code | JDT |
| Date Received | 2002-10-09 |
| Returned To Mfg | 2002-09-09 |
| Model Number | NA |
| Catalog Number | 11-104509 |
| Lot Number | 517320 |
| ID Number | NA |
| Device Expiration Date | 2001-02-01 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 410381 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | PO BOX 587 WARSAW IN 465810587 US |
| Baseline Brand Name | MALLORY/HEAD IL FEMORAL W/NTS |
| Baseline Generic Name | PROSTHESIS, HIP, COMP. |
| Baseline Model No | NA |
| Baseline Catalog No | 11-104509 |
| Baseline ID | NA |
| Baseline Device Family | M/H INTERLOK (NTS) |
| Baseline Shelf Life Contained | A |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K920161 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2002-10-09 |