MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-07 for HR005, M/L ALEXIS ORTHO PROT 5/BX 101428901 manufactured by Applied Medical Resources.
[102127084]
No product is being returned for evaluation, but a lot # is provided. A device history report is to be reviewed by engineering. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[102127085]
Procedure performed: "total hip arthroplasty. " event description: "[surgeon] from (b)(6) hospital was doing a total hip arthroplasty (posterior approach) during the end of the case when he was putting in the femoral implant, it got caught on the alexis unbeknownst to him an the staff. When [surgeon] tried to remove the alexis after the implants were placed, he noticed that the femoral implant was caught on the alexis. This required [surgeon] to have to cut the alexis from the implant and then remove the implant to remove the torn piece of alexis that was caught in it. Having the alexis caught in the implant made him weary of the device because he hadn't noticed it, there could've been a piece of the alexis left in thr patient. " type of intervention: "this required [surgeon] to have to cut the alexis from the implant and then remove the implant to remove the torn piece of alexis that was caught in it. " patient status: "no patient injury. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00081 |
| MDR Report Key | 7322571 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-07 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-02-06 |
| Date Mfgr Received | 2018-02-06 |
| Device Manufacturer Date | 2017-09-01 |
| Date Added to Maude | 2018-03-07 |
| 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 Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HR005, M/L ALEXIS ORTHO PROT 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-03-07 |
| Model Number | HR005 |
| Catalog Number | 101428901 |
| Lot Number | 1305916 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-07 |