MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HEAD DIA38/ 0MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Noise, Audible (3273)

Patient Problems Hypersensitivity/Allergic reaction (1907); Toxicity (2333)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

This 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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions." number 10 states, "wear and/or deformation of articulating surfaces." the device is reported to be available for evaluation; however, it has not been received by zimmer biomet uk 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.

Event Description

It was reported that patient enrolled in a clinical study and underwent a total hip arthroplasty on (b)(6), 2010.Subsequently, a revision procedure was performed on (b)(6) 2015 due to mild adverse reaction to metal debris (armd), metallosis, audible noise from the joint, and elevated metal ion levels.The modular head and acetabular cup were removed and replaced.

Manufacturer Narrative

Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

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 no evidence of product non-conformance.Root cause of the event was most likely attributed to third party debris, patient anatomy or surgical technique; however, a conclusive determination could not be made.

• Brand Name: DELTA CERAMIC FEM HEAD DIA38/ 0MM T1
• 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: 5110714
• MDR Text Key: 27022810
• Report Number: 3002806535-2015-04021
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK073102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 11/28/2015

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: Physician
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 12-115132
• Device Lot Number: 2111173
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2010
• 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
• Patient Outcome(s): Hospitalization; Required Intervention