MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES HR004, S/M ALEXIS ORTHO PROT 5/BX; KGW

Model Number	HR004
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow-up report will be sent once the results have been analyzed.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Lateral hip replacement- "the alexis ortho was placed correctly, but during the procedure there were little tears in the sheat of the alexis.The tears varied from 2mm to 2cm.The tears started to show after the biomet cup had been placed." patient status: "no patient injury".
Additional Manufacturer Narrative
The event unit was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause.Based on the customer provided description, it is possible that the sheath was torn during placement of the biomet cup.However, since the unit was not returned, the exact root cause cannot be confirmed.Applied medical reached out to the hospital and surgeon to provide information regarding use of the device to prevent further recurrences.All alexis® orthopaedic protectors are 100% inspected during the manufacturing process.Although the root cause could not be determined, 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.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: HR004, S/M 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: 6090729
• Report Number: 2027111-2016-00724
• Device Sequence Number: 958135
• Product Code: KGW
• UDI-Device Identifier: 00607915123185
• UDI-Public: (01)00607915123185(17)180715(30)01(10)1249866
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K100120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2017

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: 07/15/2018
• Device Model Number: HR004
• Device Catalogue Number: 101428801
• Device Lot Number: 1249866
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 01/09/2017; 01/16/2017
• Patient Sequence Number: 1