MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA MODULAR CERAMIC HEAD 36MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).Concomitant medical products - medical product - pn: 650-0795, ln: 1203448 biolox delta xlw-18 ins 36/44g.Pn: 124454ha, ln: 12134373 exceed abt std shell ha/pc 54 mm.Pn: 21-123206, ln: 1208994 taperloc lat.Ha/pc 12.5 mm t1.

Event Description

Patient reported an occasional grinding noise with no other complications.It is unknown if the grinding noise is emanating from the patient's right hip implant or anatomic right knee.There is no intervention currently planned.

• Brand Name: BIOLOX DELTA MODULAR CERAMIC HEAD 36MM
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6216037
• MDR Text Key: 63660162
• Report Number: 3002806535-2016-00924
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK042091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2016

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: 09/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 650-0661
• Device Lot Number: 1222843
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2006
• 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 Age: 75 YR
• Patient Weight: 101