MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DELTA CERAMIC OPTION HEAD DIA2 8; PROSTHESIS, HIP

Model Number N/A

Device Problem Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03209, 0001825034-2017-03210, 0001825034-2017-03211, 0001825034-2017-03212, and 0001825034-2017-03213.

Event Description

It was reported that the patient alleged to left hip popping and clicking approximately two years post-implantation.

Manufacturer Narrative

Concomitant medical products¿ m2a magnum pf cup p/n us157848 l/n 550400; taperloc porous coated stem p/n 51-100060 l/n 3386887; biolox option taper adapter p/n 650-1065 l/n 029020; active artiulcation e1 hip bearing p/n ep-200148 l/n 109250.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DELTA CERAMIC OPTION HEAD DIA2 8
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6565116
• MDR Text Key: 75102582
• Report Number: 0001825034-2017-03210
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 381370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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 Weight: 66