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

Catalog Number 75007448

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 01/11/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to due to breakage of the nanos stem and the ceramic ball head delta s36.

Manufacturer Narrative

Results of investigation: it was initially reported that a revision surgery was performed, due to "breakage of a nanos stem".With reception of the revision surgery report, it became clear that the stem was only damaged, however that the ball head (75007448, c1210928) was broken.During the revision surgery the s+n ball head, the nanos stem (ohst medizinaltechnik ag) and the inlay (third party manufacturer) were revised.How exactly the ball head, used in treatment, broke is not known, the patient was in pain and reported audible "crack".The medical documentation was reviewed.No x-rays and ct were provided, therefore the reported fracture cannot be confirmed.The root cause cannot be definitely concluded based on the available information.The batch records were reviewed, there were no deviations from standard manufacturing processes found.A material certificate review at the supplier did not show any deviations.A complaint history review did not show any further complaint for the batch in question.The risk of an ball head fracture is covered through the corresponding risk management files.In the ifu (12.23.Ed 05/16) implant fractures are listed as potential risks.To what extent the combination of the ball head and the third party inlay contributed to the fracture cannot be assessed.Based on the available information, the failure mode cannot be confirmed.The root cause cannot be established.If further information or the ball head becomes available, this complaint will be reassessed.To date, the need for further action is not indicated.Smith and nephew will monitor this device for further similar incidents.

• Brand Name: BIOLOX DELTA CE BALL HEAD 12/14 36S
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10286396
• MDR Text Key: 199243701
• Report Number: 9613369-2020-00146
• 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: 10/01/2020

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: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 75007448
• Device Lot Number: C1210928
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention