MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-09-14 for M/H INTERLOK (NTS) 11-104509 manufactured by Biomet, Inc..
[208822]
It was reported that left total hip arthroplasty was performed in 1991. Revision performed in 1998, due to fracture of femoral stem prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2001-00081 |
| MDR Report Key | 351781 |
| Report Source | 00 |
| Date Received | 2001-09-14 |
| Date of Report | 2001-08-14 |
| Date of Event | 1998-12-12 |
| Date Mfgr Received | 2001-08-14 |
| Device Manufacturer Date | 1991-05-01 |
| Date Added to Maude | 2001-09-19 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BETH ALBERT, ASST. |
| Manufacturer Street | P.O. 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 |
| Remedial Action | RC |
| 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 | 2001-09-14 |
| Model Number | NA |
| Catalog Number | 11-104509 |
| Lot Number | 716380 |
| ID Number | NA |
| Device Expiration Date | 2001-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 341062 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | P.O. 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 | 2001-09-14 |