MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-10-19 for M/H INTERLOK (NTS) 11-104507 manufactured by Biomet, Inc..
[27421]
Device implanted on 9/4/91. Stem component fractured and was revised on 8/19/96.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-1996-00016 |
| MDR Report Key | 43782 |
| Report Source | 07 |
| Date Received | 1996-10-19 |
| Date of Report | 1996-09-20 |
| Date of Event | 1996-08-19 |
| Date Mfgr Received | 1996-09-18 |
| Device Manufacturer Date | 1991-08-01 |
| Date Added to Maude | 1996-10-23 |
| 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 | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M/H INTERLOK (NTS) |
| Generic Name | PROSTHESIS, HIP, COMP. |
| Product Code | JDT |
| Date Received | 1996-10-19 |
| Returned To Mfg | 1996-09-18 |
| Model Number | NA |
| Catalog Number | 11-104507 |
| Lot Number | 949320 |
| ID Number | 11-104507 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 44730 |
| 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 | 1996-10-19 |