MAUDE Adverse Event Report: BIOMET UK LTD. TAPERLOC LAT PC 17.5 MM 12/14; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Device availability - the device is reportedly available for evaluation; however, it has not been received by zimmer biomet (b)(4) to date.In the event that the device is received and evaluated, a follow-up report will be sent to the fda to provide results.Not yet returned.

Event Description

It was reported that patient underwent a total hip arthroplasty on an unknown date.During the procedure, the surgeon noted the label on the femoral stem package indicated a different size than the actual stem inside the package.Another device was available to complete the procedure with a delay of 10 minutes.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found evidence of product non-conformance.During the evaluation, the femoral stem packaging showed evidence of incorrect labeling.Root cause of the event was determined to be due to operator error.Corrective actions have been initiated to address the reported issue.

• Brand Name: TAPERLOC LAT PC 17.5 MM 12/14
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: daniel tilbury ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 5489829
• MDR Text Key: 39989974
• Report Number: 3002806535-2016-00110
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 650-0353
• Device Lot Number: 1463373
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1