MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. LIMA HIP; LIMA REVISION BODY, LAT. 110MM

Catalog Number 428-01-110

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 12/11/2014

Event Type  Injury  

Event Description

Second revision surgery - due to the patient's anatomy; there has been a recurring issue with the patient.(b)(4).

Manufacturer Narrative

Hospital kept.

Manufacturer Narrative

The reason for this revision surgery was to address a patient's knee instability after 30 days in vivo.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.It was reported the hospital kept the device, it was not made available to djo surgical for examination.A review of the device history records (dhrs) showed no non-conforming material reports associated with this product.A review of the dhr inspection sheets for this product reveals no discrepancies or deviations in the manufacture of this product.A review of the product complaint report history showed this is the second complaint against a part from this lot.The product complaint states that the root cause of this complaint was due to the patient's anatomy.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. 110MM
• 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: 4350516
• MDR Text Key: 5217727
• Report Number: 1644408-2014-00800
• 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: 12/11/2014

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: 03/31/2016
• Device Catalogue Number: 428-01-110
• Device Lot Number: 1100565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2011
• 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: 61 YR