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

Model Number 430-98-054

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Revision surgery - revision due to length discrepancy.Removed and replaced the original shell, liner, screws, head and sleeve.

Manufacturer Narrative

The reason for this revision surgery was reported as length discrepancy.The previous surgery and the revision detailed in this investigation occurred over 10 months and 2 weeks apart.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 components used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products 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 devices 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 length discrepancy.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.There are many factors that may contribute to the event that are outside the control of djo surgical fracture, degenerative disorders, shortening of soft tissues, joint contractures, osteolysis, bone deterioration.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any patient activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FMP 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: 8846898
• MDR Text Key: 152834643
• Report Number: 1644408-2019-00719
• 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: 08/28/2019

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: 12/16/2023
• Device Model Number: 430-98-054
• Device Catalogue Number: 430-98-054
• Device Lot Number: 590G1231
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 08/01/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 010-55-020 LOT 005A1146; 010-55-020 LOT 005A1253; 010-55-020 LOT 005A1255; 411-00-035 LOT 903B1997; 497-40-000 LOT 641C1090; 932-40-754 LOT 017V1005; 010-55-020 LOT 005A1146; 010-55-020 LOT 005A1253; 010-55-020 LOT 005A1255; 411-00-035 LOT 903B1997; 497-40-000 LOT 641C1090; 932-40-754 LOT 017V1005
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR