MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-26 for RING LOC B STD 989820 & 38X58 MM 93965 manufactured by Biomet, Inc..
[29238929]
Patient Sequence No: 1, Text Type: N, H10
[29238930]
Male patient had surgery several years ago for total hip arthroplasty and has had pain w/hip flexion and had revision on approximately one year ago. The head was removed from the stem. The patient was found to have mild fretting and mild corrosion on both the head and the stem morse taper.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5177084 |
| MDR Report Key | 5177084 |
| Date Received | 2015-10-26 |
| Date of Report | 2015-10-13 |
| Date of Event | 2014-10-29 |
| Report Date | 2015-10-13 |
| Date Reported to FDA | 2015-10-13 |
| Date Reported to Mfgr | 2015-10-13 |
| Date Added to Maude | 2015-10-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RING LOC |
| Generic Name | PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL |
| Product Code | KWB |
| Date Received | 2015-10-26 |
| Catalog Number | B STD 989820 & 38X58 MM 93965 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | 56 EAST BELL DRIVE PO BOX 587 WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-26 |