MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-10-28 for SIGNATURE KNEE GUIDES 04-05 N/A 42-422461 manufactured by Biomet Orthopedics.
[2217997]
Patient reported to have undergone total knee arthroplasty on (b)(6), 2009 and alleges loss of function of his knee due to misaligned, ill positioned knee implant. A revision procedure has not been reported to date.
Patient Sequence No: 1, Text Type: D, B5
[9369598]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of receiving certificate of conformance showed that lot released with no recorded anomaly or deviation. This report is number 4 of 4 mdrs filed for the same event (reference 1825034-2011-00949 / 00952).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2011-00952 |
| MDR Report Key | 2313007 |
| Report Source | 04 |
| Date Received | 2011-10-28 |
| Date of Report | 2011-10-02 |
| Date Mfgr Received | 2011-10-02 |
| Device Manufacturer Date | 2009-09-16 |
| Date Added to Maude | 2011-10-28 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CRAIG BUCHMAN |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIGNATURE KNEE GUIDES 04-05 |
| Generic Name | SURGICAL GUIDE |
| Product Code | BWN |
| Date Received | 2011-10-28 |
| Model Number | N/A |
| Catalog Number | 42-422461 |
| Lot Number | 004408 |
| ID Number | N/A |
| Device Expiration Date | 2010-03-30 |
| 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 EAST BELL DRIVE WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-10-28 |