MAUDE Adverse Event Report: SMITH&NEPHEW, INC SL-PLUS; SL-PLUS MIA STEM TI/HA, SIZE

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 09/12/2012

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to aseptic loosening.

• Brand Name: SL-PLUS
• Type of Device: SL-PLUS MIA STEM TI/HA, SIZE
• Manufacturer (Section D): SMITH&NEPHEW, INC; schachenallee 29; aarau CH50 00; SZ CH5000
• Manufacturer (Section G): SMITH&NEPHEW, INC; schachenallee 29; aarau CH50 00; SZ CH5000
• Manufacturer Contact: phillip emmert ; 1450 e. brooks rd; memphis, TN 38116 ; 9013995296
• MDR Report Key: 3775336
• MDR Text Key: 4373246
• Report Number: 9613369-2014-00063
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 04/28/2014
• 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
• Treatment: PART NO:ASKU -CERA BALL HD, SIZE 36S - LOT NO:ASKU; PART NO:ASKU-X-LINKED PE INLAY - LOT NO: ASKU
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR