MAUDE Adverse Event Report: ENCORE MEDICAL L.P. X-ALT HIP INSTRUMENT; HXL/FMP ACETABULAR TRIAL LINER, NON-HOODED 36MM ID 52MM CUP OD

Model Number	803-51-361
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - due to the surgeon noticing a small metal object near the acetabulum component, during the routine post operation x-ray.Upon further observation, it was determined that the metal object was the locking ring off an acetabulum trial liner.The surgeon determined that the object was not a risk as is and would be monitored.
Additional Manufacturer Narrative
The reason for this complaint is to report the acetabulum trial liner's locking ring was noticed during a post operation x-ray near the acetabulum component.This event occurred during surgery.There was another suitable device available, the incident did not cause a delay in surgery, surgery was completed as intended, there was no risk or adverse event reported and the instrument was inspected prior to surgery and was found to be acceptable.The acet trial liner was not released by the hospital.When the reported event occurred the instrument may have been in service for over 2.8 years.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.Summary of complaints: 1 for fit, 1 for missing component, 1 broke/cracked/damaged.There are no previous investigations against this lot.This event is attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or issue.There are no indications that this instrument has a design or material deficiency therefore no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.

• Brand Name: X-ALT HIP INSTRUMENT
• Common Device Name: HXL/FMP ACETABULAR TRIAL LINER, NON-HOODED 36MM ID 52MM CUP OD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 6938518
• Report Number: 1644408-2017-00855
• Device Sequence Number: 16368590
• Product Code: FZX
• UDI-Device Identifier: 00888912097017
• UDI-Public: (01)00888912097017
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K072154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: Health Professional
• Device Model Number: 803-51-361
• Device Catalogue Number: 803-51-361
• Device Lot Number: 072F1901
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR