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

Catalog Number UNKN1102902

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

In a scientific publication, author: li guoqing et all, "efficacy of bipolar artificial femoral head replacement in the treatment of unstable intertrochanteric fractures in elderly patients" it was reported that the patient underwent an extended stem revision due to periprosthetic fracture.There were three types of stem used on this study, the sl-plus stem and 2 competitor devices.There is not enough information in other to determine which device was used on each patient.

Manufacturer Narrative

The study of li guoqing [1] reports the use of devices in patients with complications, in which an sl-plus stem was used.It was reported that the patient underwent an extended stem revision due to 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 ifu (lit.No.12.23 ed.05/16) states bone fracture as a known possible but very rare side effect resulting from a hip arthroplasty.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]: li guoqing; zhejiang medicine, 2018: http://dx.Doi.Org/10.12056/j.Issn.1006-2785.2018.40.16.2017-2023.

• 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: 9772754
• MDR Text Key: 187015971
• Report Number: 9613369-2020-00039
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNKN1102902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention