MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2002-11-20 for RINGLOC FULL HEMI SLD/APX SHELL 14-104052 manufactured by Biomet, Inc..
[20761919]
Report received from hospital stating that during the time period from event date to 11/2002, eleven total joint and/or revision procedures were performed, with five of these cases resulting in post operative infection. The procedures performed are comprised of various components being implanted. The company has no info that these incidents of infection are in any way related to the biomet device. The company is continuing to gather further info, but to date there is no common thread involving the device or its components that would lead biomet to conclude that the device caused any infection. Investigation continues at the hospital for non-device related causes. Right "tha" performed in 2002, resulting in post-operative infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2002-00138 |
| MDR Report Key | 429001 |
| Report Source | 06,07 |
| Date Received | 2002-11-20 |
| Date of Report | 2002-11-08 |
| Date of Event | 2002-10-17 |
| Date Mfgr Received | 2002-11-08 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2002-11-25 |
| 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 | 0 |
| Manufacturer Contact | BETH ALBERT, AST |
| Manufacturer Street | PO 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 | RINGLOC FULL HEMI SLD/APX SHELL |
| Generic Name | PROSTHESIS, HIP, COMP. |
| Product Code | KMC |
| Date Received | 2002-11-20 |
| Model Number | NA |
| Catalog Number | 14-104052 |
| Lot Number | 583330 |
| ID Number | NA |
| Device Expiration Date | 2012-06-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 418018 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | PO BOX 587 WARSAW IN 465810587 US |
| Baseline Brand Name | RINGLOC FULL HEMI SLD/APX SHELL |
| Baseline Generic Name | PROSTHESIS, HIP, COMP |
| Baseline Model No | NA |
| Baseline Catalog No | 14-104052 |
| Baseline ID | NA |
| Baseline Device Family | RINGLOC FULL HEMI SLD/APX SHELL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 120 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K853259 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2002-11-20 |