MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. LIMA HIP; LIMA REVISION BODY, LAT. 60MM

Catalog Number 428-01-060

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/24/2014

Event Type  Injury  

Event Description

Revision surgery - due to a leg length discrepancy.The surgeon had to remove the proximal body and biolox head.He used our lima revision body to replace the proximal body, but used a different vendor for the head.The lima revision stem was left in the patient.

Manufacturer Narrative

The reason for this revision surgery was to remedy a patient's leg length issue by replacing the existing components with a more suitable implant combination after 8 months of patient use.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 device history records showed no non-conforming material reports associated with this product.(b)(4).The event is deemed to be non-product related and the result of patient leg length issues.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: LIMA HIP
• Type of Device: LIMA REVISION BODY, LAT. 60MM
• 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: 4139676
• MDR Text Key: 4929975
• Report Number: 1644408-2014-00619
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092331
• 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: 09/24/2014

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: 07/31/2018
• Device Catalogue Number: 428-01-060
• Device Lot Number: 1307589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2013
• 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: 400-03-282,LOT 53985869
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR