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

Device Problem Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Signs of loosening of the sl-plus mia stem (lucent line proximal site).Pain in the left hip, no trauma event.It has not been reported whether a revision surgery has taken place.

• Brand Name: SL-PLUS MIA STEM WITH TI/HA
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 5001 ; SZ 5001
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5001 ; SZ 5001
• Manufacturer Contact: markus pöttker
• MDR Report Key: 6566513
• MDR Text Key: 75143526
• Report Number: 9613369-2017-00030
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K122296
• 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: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• 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): Disability
• Patient Age: 45 YR