MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BIOLOX OPTION CE BALL HEAD 12/14 36XL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 75007737

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 06/01/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to disassociation of the head and the stem.The redapt stem and the biolox head were removed.

Manufacturer Narrative

It was reported that a revision surgery was performed due to a disassociation of the devices.The redapt stem and the head were removed.The associated redapt femoral standard offset sleeveless stem and biolox head, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.The complaint was reported to ceramtec for the head.As the legal manufacturer of the head, ceramtec will perform the investigation on this part.Our investigation including the review of manufacturing records of the stem did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the stem revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.No further medical assessment can be performed at this time.Possible causes could include but are not limited to lack of engagement with host bone or improper surface texture.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: BIOLOX OPTION CE BALL HEAD 12/14 36XL
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9448877
• MDR Text Key: 170216336
• Report Number: 1020279-2019-04371
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• 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: 04/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 75007737
• Device Lot Number: 7010874054
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR