MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 5 NON-CEMENTED PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 75002703

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that, after a right tha had been performed on (b)(6) 2010, the patient experienced loosening of the femoral stem and acetabular cup. A revision surgery was performed on (b)(6) 2019 to treat this adverse event. During this procedure, all components of the right tha hip construct were explanted. The patient's health status is not known. This information was provided by the (b)(6), following a review of the data conducted in september 2021. Further information will not become available.

• Brand Name: SL-PLUS STANDARD STEM 5 NON-CEMENTED
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14131567
• MDR Text Key: 289446147
• Report Number: 9613369-2022-00115
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/15/2016
• Device Model Number: 75002703
• Device Catalogue Number: 75002703
• Device Lot Number: F0900886
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/16/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/16/2022 Patient Sequence Number: 1