MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BICON-PLUS PE INSERT ANTIL 5/32 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 75003589

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 08/20/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to mobilization of the stem and wear of the polyethylene.

Manufacturer Narrative

Results of investigation:it was reported that a revision surgery was performed due to mobilization of the sl-plus stem and wear of the bicon-plus pe insert.As of today, no device has been returned for investigation.An appropriate evaluation of the complained devices could therefore not be conducted.No medical records have been provided.The reported event could not be assessed and a thorough medical assessment could not be performed.A review of the batch record revealed no deviation from the standard manufacturing process for both devices in scope.The devices have been manufactured in 2006.A review of the complaint history revealed one other complaint for the batch of the sl-plus stem.No other complaint has been reported for the batch of the bicon-plus pe insert.The ifu (li.No.12.23 ed 05/16) states "wear and loosening of the implant" as possible risk factors in combination with the implantation of a hip prosthesis.The executed investigation steps give no indication that the device failed to match specification at the time of manufacturing.However, based on available information it is not possible to determine the root cause for the reported issue conclusively.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 devices in scope be returned.

• Brand Name: BICON-PLUS PE INSERT ANTIL 5/32 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 9252692
• MDR Text Key: 164488312
• Report Number: 9613369-2019-00081
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K992154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2020

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: 12/28/2012
• Device Catalogue Number: 75003589
• Device Lot Number: 0512027640
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 09/30/2019
• Supplement Dates FDA Received: 11/05/2019; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 75002756 SL-PLUS STEM LATERAL 4,LOT: C0602511
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR