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

Device Problem Unstable (1667)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Event Description

Scientific publication, author: xiong chao, "clinical comparative study of the efficacy of hip resurfacing and total hip replacement".It was reported that in 1 hip a closed reduction was performed due to dislocation at the upper posterior part of the joint.In this paper were discussed a total of 14 hips involving sl-plus cementless femoral stem.

Manufacturer Narrative

The study of xiong chao [1] reports surgeries on 39 hips, in 32 of which an sl-plus stem, used in treatment, was used.It is reported, that in one case the patient suffered from a dislocation.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]: xiong chao; clinical comparative study of the efficacy of hip resurfacing and total hip replacement; graduate school of tianjin medical university; may 2014, master dissertation.

• Brand Name: UNKN. SL-PLUS 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: 9774143
• MDR Text Key: 181650248
• Report Number: 9613369-2020-00047
• 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: 04/23/2020

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: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention