MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-10-22 for M/H INTERLOCK (NTS) 11-104507 manufactured by Biomet, Inc.
[28812]
Device was implanted on 2/27/91. Revision surgery was performed on 9/25/96, due to fracture of stem component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-1996-00021 |
| MDR Report Key | 52517 |
| Report Source | 07 |
| Date Received | 1996-10-22 |
| Date of Report | 1996-10-08 |
| Date of Event | 1996-09-25 |
| Date Facility Aware | 1996-09-25 |
| Report Date | 1996-10-08 |
| Date Mfgr Received | 1996-09-27 |
| Device Manufacturer Date | 1991-01-01 |
| Date Added to Maude | 1996-12-03 |
| 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 |
| Removal Correction Number | Z106410695 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M/H INTERLOCK (NTS) |
| Generic Name | PROSTHESIS, HIP, COMP. |
| Product Code | JDT |
| Date Received | 1996-10-22 |
| Returned To Mfg | 1996-09-27 |
| Model Number | NA |
| Catalog Number | 11-104507 |
| Lot Number | 367300 |
| ID Number | PART# 11-104511 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 53162 |
| 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 | 1996-10-22 |