MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-11-19 for 19MM ACL SUTURE BUTTON N/A 904219 manufactured by Biomet Orthopedics.
[16797800]
It was reported a patient underwent acl reconstruction on (b)(6) 2013. Subsequently, the patient? S knee became infected on (b)(6) 2013. It is unknown if the patient has been revised. No further information has been provided to date.
Patient Sequence No: 1, Text Type: D, B5
[16972419]
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. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states,? Early or late postoperative infection and allergic reaction? Review of sterilization certification confirms device was sterilized in accordance with (b)(4). This report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2013-05419/05420).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-05420 |
| MDR Report Key | 3477616 |
| Report Source | 01,07 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-10-24 |
| Date of Event | 2013-10-11 |
| Date Mfgr Received | 2013-10-24 |
| Device Manufacturer Date | 2013-05-11 |
| Date Added to Maude | 2013-11-20 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. AMANDA ZAJICEK |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726782 |
| 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 | 19MM ACL SUTURE BUTTON |
| Generic Name | RETENTION DEVICE, SUTURE |
| Product Code | KGS |
| Date Received | 2013-11-19 |
| Model Number | N/A |
| Catalog Number | 904219 |
| Lot Number | 386490 |
| ID Number | N/A |
| Device Expiration Date | 2018-05-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-11-19 |