MAUDE Adverse Event Report: ENCORE MEDICAL L.P. BIOLOX DELTA HIP; HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM NEUTRAL

Model Number 400-03-402

Device Problem Wrong Label (4073)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2022

Event Type  Injury  

Manufacturer Narrative

The reason for this complaint was reported as mislabeling.The healthcare professional indicated that this event occurred during inspection, away from the patient.The incident did not cause a delay in surgery.The device was inspected prior to use and found to be unacceptable.The agent was present when this event occured and did not have another suitable device available.The device was not returned to the manufacturer and not made available at djo surgical for examination.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design requirements.There were no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.On the label proof the outer packaging does state "blue" however, the sticker that was placed states "sky blue", this discrepancy was not captured during the manufacturing process.A review of the complaint database resulted in one complaint with a similar failure.The review does not show present trends or on-going issues that are needing a review.The correct information about the device is located on the outer packaging, the lot number and part number are correct and the image of the device is correct.The reported lot number is not available to review the label.No additional containment is necessary.The root cause of this complaint is likely due to human error.The individual did not select the correct label to place on the outer packaging.The pick list has the correct label, blue, listed.During the dhr review, the reviewer noted that the correct colored sizing label was applied to the label dhr.This is likely due to human error.Rma examination: the reported device will not be returned to surgical for evaluation.The agent stated that the device will not be returned.

Event Description

Complaint - sterile box has "sky blue" sticker & this should have had a "blue" sticker instead.

• Brand Name: BIOLOX DELTA HIP
• Type of Device: HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15970175
• MDR Text Key: 305363823
• Report Number: 1644408-2022-01687
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00888912023306
• UDI-Public: (01)00888912023306
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2022

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 Model Number: 400-03-402
• Device Catalogue Number: 400-03-402
• Device Lot Number: 871B1421
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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