MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EXPRT HIP; EXPRT REVISION HIP, STANDARD OFFSET PROXIMAL BODY, 65MM

Catalog Number	495-00-065
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Reported incident - exprt locking bolt shown on one-month post operative x-ray as out of position, indicating loosening.
Additional Manufacturer Narrative
(b)(4).Upon further quality assurance evaluation, the data for that part was removed as the specific component used in the surgery could not be confirmed.Manufacturer narrative: the reason for this complaint was to report an expert bolt was showing proud on a 1-month follow up x-ray.The patient was asymptomatic.No additional information is available at this time.Surgery records were reviewed for the date range indicated.The specific component used in the surgery could not be confirmed.The bolt / hole geometry is uniform throughout the product family.Original date of surgery is unknown.There has been no notification of intent to revise the patient.Device history record review was not conducted as the specific part/lot was not identified for this issue.3 previous complaints have been received for this issue.(b)(4), corrective action (ca), was opened to provide a complete root cause investigation and to determine corrective action.Root cause: (b)(4), health hazard evaluation (hhe), was completed to assess patient risk, root cause and containment requirements.
Additional Manufacturer Narrative
The reason for this complaint was to report an exprt bolt was showing proud on a 1-month follow up x-ray.The patient was asymptomatic.No additional information is available at this time.Surgery records were reviewed for the date range indicated.495-00-065 exprt revision hip, standard offset proximal body, 65mm, was identified as representative of the primary component although another size proximal body could have been used.The bolt / hole geometry is uniform throughout the product family.Original date of surgery is unknown.There has been no notification of intent to revise the patient.Device history record review was not conducted as the specific part/lot was not identified for this issue.3 previous complaints have been received for this issue.Ca-01196, corrective action (ca), was opened to provide a complete root cause investigation and to determine corrective action.Root cause: hhe-2018-00002, health hazard evaluation (hhe), was completed to assess patient risk, root cause and containment requirements.

• Brand Name: EXPRT HIP
• Common Device Name: EXPRT REVISION HIP, STANDARD OFFSET PROXIMAL BODY, 65MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7975253
• Report Number: 1644408-2018-00974
• Device Sequence Number: 1755958
• Product Code: KWZ
• UDI-Device Identifier: 00190446153818
• UDI-Public: (01)00190446153818
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2019

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: Health Professional
• Device Catalogue Number: 495-00-065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 02/04/2019; 02/20/2019
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 02/11/2019; 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other