MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. SL-PLUS STEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNKNOWN

Device Problem Osseointegration Problem (3003)

Patient Problems Erosion (1750); Bone Fracture(s) (1870)

Event Date 06/13/2009

Event Type  Injury  

Event Description

It was reported that, on literature review ""cementless total hip replacement: a (b)(6) study of the early functional and radiological outcomes of three different hip stems"", a (b)(6) year old male patient who had initially a sl-plus stem implanted experienced radiolucent lines up to 3 mm in the proximal part of the femur due to stress shielding at 12 months postoperatively.In addition, a greater trochanter apex fracture could be detected at the second postoperative evaluation.No progression of the radiolucent lines was seen 12 months postoperatively and the stem delivered satisfactory clinical results as reported by the authors.Further information on the patient's current health status is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).Bergschmidt, p., bader, r., finze, s., gankovych, a., kundt, g., & mittelmeier, w.(2010).Cementless total hip replacement: a prospective clinical study of the early functional and radiological outcomes of three different hip stems.Archives of orthopaedic and trauma surgery, 130(1), 125-133.10.1007/s00402-009-0907-8.

• Brand Name: UNKN. SL-PLUS STEM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 13480004
• MDR Text Key: 285229224
• Report Number: 9613369-2022-00021
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male