MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-05 for COLLECT.NO.QAS KNEE IMPLANTS VEGA AE-QAS-K521-56 manufactured by Aesculap Implant Systems.
[96719768]
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[96719769]
Country of complaint: usa. About a year ago, a surgeon implanted a vega total knee at (b)(6). Upon follow up, the vega tibial component has loosened. They became aware that this occasionally happens; however, the surgeon now has confirmed that this in not an isolated incident. He now has two patients that have confirmed loose tibia baseplates (and they are in need of revision). Additionally, he is "keeping a close eye on" two more patients that he suspects have loose tibias. This is a total of 4 patients. All patients reported are less than a year post op. The surgeon suspects that this issue may have come from surgical technique. Initially, he implanted the tibial, femoral, and meniscal components into the patient and locked the poly screw into place before the cement had a chance to harden. Apparently, the surgeon was informed that this a improper technique - he should wait until the cement has hardened before the poly screw is implanted. He has since changed his surgical technique. If this is the reason why there are loose tibia baseplates in his patients, then the problem is solved (hopefully we don't see any more loosening). No injury to patient. No delay in surgery. No additional intervention required. All med watch submissions related to this report are: 9610612-2018-00005, 9610612-2018-00006.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00005 |
| MDR Report Key | 7169986 |
| Date Received | 2018-01-05 |
| Date of Report | 2018-02-26 |
| Date Facility Aware | 2018-01-02 |
| Date Mfgr Received | 2017-12-15 |
| Date Added to Maude | 2018-01-05 |
| 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 | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COLLECT.NO.QAS KNEE IMPLANTS VEGA |
| Generic Name | KNEE ENDOPROSTHETICS |
| Product Code | HSH |
| Date Received | 2018-01-05 |
| Model Number | AE-QAS-K521-56 |
| Catalog Number | AE-QAS-K521-56 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP IMPLANT SYSTEMS |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-05 |