MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-08 for IBAL PATELLA IMPL DOME,37X 10 MM AR-504-PSD0 manufactured by Arthrex, Inc..
[123069236]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified. The cause of the event could not be determined from the information available and without device evaluation. A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure. Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials. Patient sensitivity to materials must be considered prior to implantation.
Patient Sequence No: 1, Text Type: N, H10
[123069237]
It has been reported that on (b)(6) 2015 a patient underwent a total knee procedure. The tibial tray implanted during this procedure was ar-503ttth, lot 1380710. Patient developed a serious infection in his knee which required having to have fluid drawn from his knee, the parts then had to be explanted in a second surgery where a temporary spacer was put in place, he then underwent a lengthy series of iv antibiotics and eventually had another surgery to redo the knee with new implants. Patient is currently doing well. Patient did not have all of his records available at the time of call so additional information has been requested. Additional information obtained 9/21/2018: patient underwent a right tka procedure on (b)(6) 2015 during which the following devices were implanted: tibial tray implant ar-503-ttth lot 1380710, femoral implant ar-516-7r lot 1355182, tibial bearing implant ar-513-bh12 lot 113601341, and patella implant ar-504-psd0 lot 113601439. Almost immediately after having the procedure the patient began to have infection symptoms which included: swelling, redness and the incision was leaking fluid including blood. On (b)(6) 2015 the patient's knee was drained to provide some relief however the symptoms did not dissipate and continued. On (b)(6) 2016 the patient underwent surgery with a different surgeon at a different facility. During the procedure the four original tka implants were explanted and a temporary spacer was inserted. New implants could not be inserted until the infection was allowed to clear over 6 weeks and the patient underwent iv antibiotic treatment. On (b)(6) 2016 the second surgeon then went back in (at the same facility as the second surgery) and was able to insert another manufacturer's tka implants. At time of report patient is doing well. Patient is unaware if the devices were kept by the facility or not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2018-00695 |
| MDR Report Key | 7943603 |
| Date Received | 2018-10-08 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-09-17 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2014-12-22 |
| Date Added to Maude | 2018-10-08 |
| 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 | IBAL PATELLA IMPL DOME,37X 10 MM |
| Generic Name | PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Product Code | KRR |
| Date Received | 2018-10-08 |
| Model Number | IBAL PATELLA IMPL DOME,37X 10 MM |
| Catalog Number | AR-504-PSD0 |
| Lot Number | 113601439 |
| Device Expiration Date | 2019-11-30 |
| 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 | 2018-10-08 |