MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-19 for RINGLOC SCREWIN PROV +3/HW 36 SZ23 N/A 31-108323 manufactured by Biomet Orthopedics.
[2730948]
It was reported that patient underwent total hip arthroplasty on (b)(6) 2012. During the procedure, as the acetabular cup was impacted, the locking ring came out. After trialing, the trial liner was difficult to remove. Subsequently, the surgeon installed a new locking ring in the acetabular cup, but had difficulties locking the acetabular liner in place. The surgeon used a different acetabular cup, liner, modular head, and taperloc stem to complete the procedure. A delay of more than half an hour occurred.
Patient Sequence No: 1, Text Type: D, B5
[9924429]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[10053599]
Visual inspection of trial shows signs of damage on the scallops from the attempts at removal. There are additionally two areas with minor damage/scuffing in the ring groove that appear near the scallop damage, also presumably from removal. Dimensions for the locking ring groove met specifications. The reported event could not be substantiated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00883 |
| MDR Report Key | 2621239 |
| Report Source | 07 |
| Date Received | 2012-06-19 |
| Date of Report | 2012-05-24 |
| Date of Event | 2012-05-22 |
| Date Mfgr Received | 2012-05-24 |
| Device Manufacturer Date | 2011-11-03 |
| Date Added to Maude | 2012-06-19 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGELA DICKSON |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RINGLOC SCREWIN PROV +3/HW 36 SZ23 |
| Generic Name | TEMPLATE |
| Product Code | IQO |
| Date Received | 2012-06-19 |
| Returned To Mfg | 2012-06-05 |
| Model Number | N/A |
| Catalog Number | 31-108323 |
| Lot Number | 053360 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-19 |