MAUDE Adverse Event Report: AARAU SWITZERLAND MANUFACTURING SITE SL PLUS MIA STEM LATERAL 5 NON-CEM; HIP IMPLANT

Catalog Number 75001955

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2014

Event Type  Injury  

Event Description

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

• Brand Name: SL PLUS MIA STEM LATERAL 5 NON-CEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): AARAU SWITZERLAND MANUFACTURING SITE; schachenallee 29; aarau
• Manufacturer (Section G): AARAU SWITZERLAND MANUFACTURING SITE; schachenallee 29; aarau ; SZ
• Manufacturer Contact: connie mcbroom ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 3815238
• MDR Text Key: 4502034
• Report Number: 9613369-2014-00070
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75001955
• Device Lot Number: A0602177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR