MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS MIA STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED

Device Problem Loss of Osseointegration (2408)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 06/06/2017

Event Type  Injury  

Event Description

It was reported a revision surgery was performed due to bone fracture.The patient fell down and resulted in fracture, pain and loosening of the stem.

• Brand Name: SL-PLUS MIA STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 6340 ; SZ 6340
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5001 ; SZ 5001
• Manufacturer Contact: markus pöttker
• MDR Report Key: 6685285
• MDR Text Key: 79025263
• Report Number: 1020279-2017-00488
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2017
• 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): Hospitalization; Required Intervention