MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES HR005, M/L ALEXIS ORTHO PROT 5/BX; KGW

Model Number	HR005
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.".
Additional Manufacturer Narrative
Investigation summary: the event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: HR005, M/L ALEXIS ORTHO PROT 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7322571
• Report Number: 2027111-2018-00081
• Device Sequence Number: 13854307
• Product Code: KGW
• UDI-Device Identifier: 00607915123192
• UDI-Public: (01)00607915123192(17)200913(30)01(10)1305916
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/13/2020
• Device Model Number: HR005
• Device Catalogue Number: 101428901
• Device Lot Number: 1305916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 05/14/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMORAL IMPLANT