MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION HIP; FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 56MM, W/P2 COATING

Model Number 400-03-401

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 07/06/2017

Event Type  Injury  

Event Description

Revision surgery: a total hip done two years ago the cup came loose and the surgeon used a liner and cup from a different company.The surgeon used a djo head and sleeve.

Manufacturer Narrative

The reason for this revision surgery was loosening of the acetabular cup.The previous surgery and the revision detailed in this investigation occurred 2 years apart.There are no reported pre-existing patient health conditions.The healthcare professional indicated 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 event.The device 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 loosening.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the loosening.There are many factors that may contribute to the event that are outside the control of djo surgical are loose joints from inadequate soft tissue support, patient bone deterioration, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was loosening of the acetabular cup.The previous surgery and the revision detailed in this investigation occurred 2 years apart.There are no reported pre-existing patient health conditions.The healthcare professional indicated 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 event.The device 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 loosening.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the loosening.There are many factors that may contribute to the event that are outside the control of djo surgical are loose joints from inadequate soft tissue support, patient bone deterioration, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.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, 56MM, W/P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 6764647
• MDR Text Key: 81739892
• Report Number: 1644408-2017-00672
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912076166
• UDI-Public: (01)00888912076166
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 400-03-401
• Device Catalogue Number: 430-98-056
• Device Lot Number: 591G1088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: 09/06/2017; 10/21/2017
• Supplement Dates FDA Received: 10/05/2017; 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR