MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 2 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 75002697

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 03/10/2014

Event Type  Injury  

Event Description

Clinical study no: (b)(4), patient study-id: (b)(6).It was reported that in the (b)(6) study for subject (b)(6) the investigator reported a stem loosening with the date of onset (b)(6) 2014.Revision surgery was performed last (b)(6).Stem and femoral head exchanged.

• Brand Name: SL-PLUS STANDARD STEM 2 NON-CEMENTED
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 10872046
• MDR Text Key: 217657361
• Report Number: 9613369-2020-00245
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K072852
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2017
• Device Catalogue Number: 75002697
• Device Lot Number: F1026836
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD 76539167, LOT 09JT35274
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 76