MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CERAMIC CERAMIC BALL HEAD FORTE 28L; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLY,CEMENT OR NON-POROUS,UNCEMENT

Catalog Number 75004171

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 08/10/2018

Event Type  Injury  

Event Description

It was reported a revision surgery due to broken ceramic ball head.

Manufacturer Narrative

Results of investigation: a revision surgery due to the fracture of a ceramic ball head was reported.Fragments of the ball head and the pe insert were returned for investigation.A review of the production documentation did not detect any deviation from the standard manufacturing processes.The density of the ball head was analysed and found complying with the delivery specification of biolox forte components.Primary metal transfer could not be found equally distributed on the cone of the ball head.No medical documents were received for investigation.Based on the available information, no specific root cause for the reported fracture could be determined.There is however to the best of our knowledge no indication that the device failed to meet specifications at the time of manufacturing.No further actions have been initiated.

• Brand Name: CERAMIC CERAMIC BALL HEAD FORTE 28L
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLY,CEMENT OR NON-POROUS,UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar, 06340 ; SZ 06340
• MDR Report Key: 7845084
• MDR Text Key: 119147886
• Report Number: 1020279-2018-01700
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K070928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

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: Lay User/Patient
• Device Catalogue Number: 75004171
• Device Lot Number: C1213557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 08/10/2018
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 75001557, MPF REXPOL INSERT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 98