MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for IBALANCE PATELLA IMPLANT DOME, 30 X 8 MM AR-504-PSB8 manufactured by Arthrex, Inc..
[128876199]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[128876200]
It was originally reported ((b)(4)) by patient's attorney that patient underwent a left total knee replacement procedure on (b)(6) 2015 during which the following arthrex products were implanted: ar-503-ttte, tibial tray, lot 1315453. Ar-516-5l, femoral implant, lot 1476178. Ar-513-be12, tibial bearing, lot 113601433. Ar-504-psb8, patella implant, lot 113601439. Surgeon office records (b)(6) 2016: patient still has some residual stiffness and mild discomfort. Patient reported old pain is gone, pain is better than before surgery. Patient has pain on and off in tibial region and reported knee will swell on occasion. Surgeon office records (b)(6) 2017: patient reported pain in both knees and pain with walking in both knees. Patient reported right knee hurts more than left knee. Patient did not improve with steroid injections. Additional information obtained (b)(6) 2018: patient underwent a revision surgery on (b)(6) 2018 due to painful left total knee arthroplasty, morbid obesity. Operative report (b)(6) 2018: all original components were explanted. Bearing was removed with compression of the tibia. The femur was found to be well fixed. Femur and patella required osteotomes and/or oscillating saw for removal. Tibia was removed with an osteotome. It delaminated from the cement. Cement was well fixed to the tibia. Negative cement mold of the tibia was present and there was no cement on the backside of the tibia. The medical records provided note that the patient is morbidly obese which is a contraindication for this device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2018-00775 |
| MDR Report Key | 8117015 |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-11-09 |
| Device Manufacturer Date | 2015-03-26 |
| Date Added to Maude | 2018-11-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IBALANCE PATELLA IMPLANT DOME, 30 X 8 MM |
| Generic Name | PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Product Code | KRR |
| Date Received | 2018-11-29 |
| Model Number | IBALANCE PATELLA IMPLANT DOME, 30 X 8 MM |
| Catalog Number | AR-504-PSB8 |
| Lot Number | 113601439 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-29 |