MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DELTA HIP; HEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM +4.0

Catalog Number 400-03-363

Device Problem Compatibility Problem (2960)

Patient Problem No Code Available (3191)

Event Date 03/22/2016

Event Type  Injury  

Event Description

Revision surgery - due to the patient's anatomy the surgeon had difficulty with the proximal portion of the taperfill.Surgeon put in large neck and head to lengthen the leg back.

Manufacturer Narrative

The reason for this revision surgery was to lengthen the leg of the taperfill.The length of the in-vivo service was 1 day.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.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.Initial or prolonged hospitalization was required.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 device history records (dhrs) revealed no discrepancies or issues with the manufacturing history of this part.All parts were found to meet design and manufacturing specifications.No non-conforming material reports (ncmr's) were associated with this part.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed to be non-product related.The root cause for lengthening the leg was the patient's anatomy had difficulty with the proximal portion of the taperfill.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions relating to this event could not be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DELTA HIP
• Type of Device: HEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM +4.0
• 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: 5591746
• MDR Text Key: 43150069
• Report Number: 1644408-2016-00240
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00888912076142
• UDI-Public: (01)00888912076142
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082844
• 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
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2021
• Device Catalogue Number: 400-03-363
• Device Lot Number: 868B1102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR