MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-11-09 for M/H INTERLOK (NTS) 11-104507 manufactured by Biomet, Inc..
[209983]
It was reported that total hip arthroplasty was performed in 1992. Proximal portion of femoral stem component loosened and subsequently fractured. Revision performed in 2001, noting intraoperatively, that the distal portion of the femoral stem remained well fixed. Both distal and proximal pieces of stem component were removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2001-00106 |
| MDR Report Key | 360655 |
| Report Source | 07 |
| Date Received | 2001-11-09 |
| Date of Report | 2001-11-09 |
| Date of Event | 2001-09-24 |
| Date Facility Aware | 2001-10-15 |
| Report Date | 2001-11-09 |
| Date Mfgr Received | 2001-10-11 |
| Device Manufacturer Date | 1991-06-01 |
| Date Added to Maude | 2001-11-21 |
| 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 |
| Manufacturer Contact | BETH ALBERT, AST. |
| Manufacturer Street | PO BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 2192676639 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NOT APPLICABLE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M/H INTERLOK (NTS) |
| Generic Name | PROSTHESIS, HIP, COMP. |
| Product Code | JDT |
| Date Received | 2001-11-09 |
| Returned To Mfg | 2001-10-11 |
| Model Number | NA |
| Catalog Number | 11-104507 |
| Lot Number | 776150 |
| ID Number | NA |
| Device Expiration Date | 2001-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 349827 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | PO BOX 587 WARSAW IN 465810587 US |
| Baseline Brand Name | M/H INTERLOK (NTS) |
| Baseline Generic Name | PROSTHESIS, HIP, COMP. |
| Baseline Model No | NA |
| Baseline Catalog No | 11-104507 |
| Baseline ID | LOT# 949320 |
| 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 | 2001-11-09 |