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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/1901

Event Type  Injury  

Event Description

Scientific publication, author: wang wenhao, "analysis of failed total hip replacement and the clinical results of revision total hip replacement".It was reported that there were 5 cases of periprosthetic fracture involving a slr-plus rectangular stem.They were treated with wire cable cerclage.In this paper there were a total of 28 cases.

Manufacturer Narrative

The study of wang wenhao [1] reports surgeries on 28 hips, in 9 an slr-plus stem, was used.It is reported that in 5 cases, the patients suffered from a periprosthetic fracture.The part and the batch number of this device are not known.Therefore, the batch record review and a complaint history review could not be performed.The reported failure mode might occur in some cases, which is stated as a side effect in the ifu lit.No.12.23 ed.05/16.The severity and the failure mode are covered through our risk management.As no device was received for investigation, a visual inspection could not be performed.No patient information nor any other medication documentation was provided, therefore, a thorough medical investigation could not be performed.Based on our investigations the failure mode cannot be confirmed and the root cause of the problem stays undetermined due to insufficient information.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.[1]: wang wenhao, analysis of failed total hip replacement and the clinical results of revision total hip replacement, medical school of shandong university, master thesis, apr 2013.

• Brand Name: UNKN. SLR-PLUS REVISION STEM
• 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: 9774027
• MDR Text Key: 181542665
• Report Number: 9613369-2020-00043
• 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: 04/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention