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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

Scientific publication, author: xu le, "the mid-term results of ceramic to ceramic coupled cementless total hip arthroplasty".It was reported that there was 1 case of aseptic loosening of femoral stem, requiring revision surgery.In this paper 64 hips were discussed involving sl-plus.

Manufacturer Narrative

The study of (b)(6) [1] reports surgeries on 64 hip, in 41 of which an sl-plus stem was used.It was reported that there was one case of aseptic loosening of femoral stem, requiring revision surgery.The part and the batch number of this device is not known.Therefore, the batch record review and a complaint history review could not be performed.Loosening of an implant after surgery might occur in some cases, which is stated as a possible risk factor 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 are deemed necessary.Smith and nephew will monitor the devices for further similar issues.[1]: (b)(6); (b)(6), 2013.(b)(6).Sign-off date: (b)(6) 2020.

• 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: 9774190
• MDR Text Key: 187013349
• Report Number: 9613369-2020-00049
• 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: 05/05/2020

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: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention