MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. TAPERFILL HIP; TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 11

Catalog Number 425-97-011

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 06/24/2015

Event Type  Injury  

Event Description

Revision surgery - there was evidence of stem subsidence.

Manufacturer Narrative

Left with surgeon.

Manufacturer Narrative

The reason for this revision surgery was reported as evidence of stem subsidence.The length of in vivo service was 3.1 months.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.Initial or prolonged hospitalization was required.The device was reported to have been left with the surgeon and not made available to (b)(4) for examination.A review of the device history records showed no non-conforming material reports associated with the main contributor component listed in the complaint.A review of the product complaint report history showed there have been 4 prior complaints reported against this part number; summary of investigations: 1 for looseness, 1 for infection, 1 for trauma, 1 for dislocation.This is the first complaint against this lot number.The surgeon reported no issues associated with the explanted product and provided no information that definitively described the root cause or reason of the subsidence.No other conditions relating to this event could be determined with confidence.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: TAPERFILL HIP
• Type of Device: TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 11
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 4880238
• MDR Text Key: 15903188
• Report Number: 1644408-2015-00382
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2015

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: 11/30/2020
• Device Catalogue Number: 425-97-011
• Device Lot Number: 176R1903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 06/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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
• Treatment: 411-00-350,LOT 931B1902; 932-44-260,LOT 755F1047
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR