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

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

Patient Problem Thrombosis (2100)

Event Date 01/01/1901

Event Type  Injury  

Event Description

In a scientific publication, author: zhu yabin et all, "observation on short-term clinical efficacy of hip replacement using cementless femoral prosthesis in elderly patients with osteoporotic femoral neck fracture" it was reported that 5 patients received conservative treatment due to intramuscular vein thrombosis in calf.These patients were implanted with sl-plus stems but there is no information regarding to the other devices or sizes implanted.

Manufacturer Narrative

*literature case* in a scientific publication, author: zhu yabin et all, "observation on short-term clinical efficacy of hip replacement using cementless femoral prosthesis in elderly patients with osteoporotic femoral neck fracture" it was reported that 5 patients received conservative treatment due to intramuscular vein thrombosis in calf.These patients were implanted with sl-plus stems but there is no information regarding to the other devices or sizes implanted.

• 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: 9772728
• MDR Text Key: 187014386
• Report Number: 9613369-2020-00032
• 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
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other