MAUDE Adverse Event Report: AESCULAP AG BIOLOX PROSTHESIS HEAD 12/14 28MM S; HIP ENDOPROSTHESES - HEADS

Model Number NK460

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: device will not be returned.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There are no indications of any pre-existing material defect.Due to a lack of ceramic parts further investigations cannot be done.Patient height and weight: unknown.Patient year of birth: (b)(4).When additional information is available, a supplement report will be submitted.

Event Description

It was reported by the healthcare professional to the company sales representative "the patient felt a cracking and rubbing in the area of the left hip without rememberable trauma and without specifiable time".There had been no fall, no severe pain in the area of the left hip, only cracking and limited movement.The original implant had been inserted in 2004.A ct was performed after the patient complaints and showed fracture of the head; and a revision was planned.Further information: operative reports and x-rays are expected.It was noted that a cup size 48 mm had been originally implanted and that a 56 mm cup was used as the replacement.Unfortunately, the explants have been lost and will not be returned.

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 28MM S
• Type of Device: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7975950
• MDR Text Key: 124066668
• Report Number: 9610612-2018-00466
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2014
• Device Model Number: NK460
• Device Catalogue Number: NK460
• Device Lot Number: 51201015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/02/2018
• Device Age: 14 YR
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2004
• 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