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 No Information (3190)

Event Date 01/11/2019

Event Type  Injury  

Event Description

It was reported that revision surgery due to breakage of the nanos stem (legal manufacturer ohst ag) and the ceramic ball head delta 36s was performed for unknown reasons.

Manufacturer Narrative

Additional information received by the customer has identified that this event has been already reported under 9613369-2020-00146.The new information confirms that this is a duplicate complaint, therefore, if further details are provided in future confirming the opposite, our files will be updated accordingly and a further report will be submitted outlining both events details and our investigations performed.

• 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: 10273781
• MDR Text Key: 198863370
• Report Number: 9613369-2020-00143
• 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

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75007448
• Device Lot Number: C1210928
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention