MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-05-03 for RINGLOC HI-WALL TRIAL LINER 3/8" SCREW SZ 25 X 44MM ID +3MM N/A 33-108725 manufactured by Biomet Orthopedics.
[9287413]
Evaluation of the returned device found evidence to suggest it failed in bending overload. This report filed (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
[16727975]
It was reported that patient underwent total hip arthroplasty utilizing trial acetabular liners on (b)(6) 2011. During the procedure, the screw separated from the trial liner and remained in the cup. The screw was removed from the cup and there was no injury to the patient or significant delay to the procedure as a result.
Patient Sequence No: 1, Text Type: D, B5
[16932065]
Review of receiving certificate of conformance showed that lot released with no recorded anomaly or deviation. Other - evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2011-00325 |
| MDR Report Key | 2074745 |
| Report Source | 07 |
| Date Received | 2011-05-03 |
| Date of Report | 2011-04-04 |
| Date of Event | 2011-04-04 |
| Date Facility Aware | 2011-05-03 |
| Date Mfgr Received | 2011-04-04 |
| Device Manufacturer Date | 2011-02-22 |
| Date Added to Maude | 2011-05-10 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. CRAIG BUCHMAN |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5743711132 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RINGLOC HI-WALL TRIAL LINER 3/8" SCREW SZ 25 X 44MM ID +3MM |
| Generic Name | DEVICE, PROSTHESIS ALIGNMENT |
| Product Code | IQO |
| Date Received | 2011-05-03 |
| Returned To Mfg | 2011-04-14 |
| Model Number | N/A |
| Catalog Number | 33-108725 |
| Lot Number | 21484703 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-03 |