MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION HIP; FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 54MM, W/P2 COATING

Model Number 430-98-054

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 03/23/2018

Event Type  Injury  

Event Description

Revision surgery - due to the initial cup having retroverted.The surgeon removed the components and replaced with new implants.

Manufacturer Narrative

The reason for this revision surgery was due to the cup having retroverted.The previous surgery and the revision detailed in this investigation occurred 1 month apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to the cup having retroverted.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION HIP
• Type of Device: FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 54MM, W/P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7404871
• MDR Text Key: 104657663
• Report Number: 1644408-2018-00306
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912084031
• UDI-Public: (01)00888912084031
• Combination Product (y/n): N
• PMA/PMN Number: K974093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2023
• Device Model Number: 430-98-054
• Device Catalogue Number: 430-98-054
• Device Lot Number: 590G1207
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 010-55-030, LOT 007A1234; 400-03-362, LOT 866B1316; 931-36-754, LOT 762N1983
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 85 YR