MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2003-01-29 for MLRY-HD POROUS FMRL PROV 104438 manufactured by Biomet, Inc..
[277810]
During total hip arthroplasty, threaded insert of the trial prosthesis dislodged and remained attached to the inserter instrument. Subsequently inserter was used to implant the prosthesis and threaded insert reportedly lodged in the prosthesis. Surgeon elected to leave threaded insert component in the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2003-00025 |
| MDR Report Key | 440375 |
| Report Source | 01,07 |
| Date Received | 2003-01-29 |
| Date of Report | 2002-12-31 |
| Date Mfgr Received | 2002-12-31 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 2003-02-03 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BETH ALBERT |
| Manufacturer Street | P.O. 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 | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MLRY-HD POROUS FMRL PROV |
| Generic Name | PROVISIONAL |
| Product Code | IQO |
| Date Received | 2003-01-29 |
| Returned To Mfg | 2002-12-31 |
| Model Number | NA |
| Catalog Number | 104438 |
| Lot Number | 184380 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 429311 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | P.O. BOX 587 WARSAW IN 465810587 US |
| Baseline Brand Name | MLRY-HD POROUS FMRL PROV |
| Baseline Generic Name | PROVISIONAL |
| Baseline Model No | NA |
| Baseline Catalog No | 104438 |
| Baseline ID | NA |
| Baseline Device Family | MLRY-HD POROUS FMRL PROV |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-01-29 |