MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. BICON-PLUS SHELL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 11/26/2019

Event Type  Injury  

Event Description

It was reported that the patient has s&n components in place since 22 years ago.Planned revision surgery was performed and the bicon cup was changed due to loosening of the cup.No other patient injury or complications were reported.

Manufacturer Narrative

Results of investigation: this complaint from germany reports a revision of a bicon-plus hip after 22 years insitu, due to loosening.Until today, the device used in treatment was not returned for evaluation nor has any article or batch number been communicated.An appropriate investigation could therefore not be conducted and the reported failure mode cannot independently be confirmed.No clinical/medical documents have been presented to support the complaint.Without supporting clinical/medical documents a thorough investigation could not be performed.A review of the device labeling revealed the ifu (lit.No.12.23 ed 05/16) states implant loosening as a known possible side effect in combination with the implantation of a hip prosthesis.Based on available information it is not possible to determine the root cause.The need for corrective action is not indicated.Smith + nephew will continue to monitor this device for similar issues.The complaint will be reopened should the device in scope be returned or additional information become available.

• Brand Name: UNKN. BICON-PLUS SHELL
• 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: 9473693
• MDR Text Key: 170903612
• Report Number: 1020279-2019-04402
• 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: 02/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention