MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS BIOLOX PROSTHESIS HEAD 12/14 32MM M; HIP ENDOPROSTHESES

Model Number NK561

Device Problem Fracture (1260)

Patient Problem Missing Value Reason (3192)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).Five year 1 month post operative fracture of ceramic head.

Manufacturer Narrative

Product was not received for investigation.The identification of the product can not be confirmed without product return.Review of protocols and quality documents was completed based on the information reported.It was found that the values obtained on the ball head were according to specification valid at the time of production.The ball head properties and the microstructures as obtained from the quality documents accomplish 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 can not be completed.The evaluation of the ceramic component is based on the investigation of the manufacturer of the broken ceramic insert (company ceramtec (b)(4)).Data is filed under (b)(4) at ceramtec (b)(4).

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 32MM M
• Type of Device: HIP ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5535543
• MDR Text Key: 41469808
• Report Number: 3005673311-2016-00046
• 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
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

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: No Information
• Device Expiration Date: 11/01/2020
• Device Model Number: NK561
• Device Catalogue Number: NK561
• Device Lot Number: 51715247
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/18/2016
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2010
• 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): Other
• Patient Age: 68 YR