MAUDE Adverse Event Report: AARAU SWITZERLAND MANUFACTURING SITE SL PLUS STANDARD STEM 3; HIP IMPLANT

Catalog Number 75002699

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 02/18/2014

Event Type  Injury  

Event Description

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

Manufacturer Narrative

(b)(4).

• Brand Name: SL PLUS STANDARD STEM 3
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): AARAU SWITZERLAND MANUFACTURING SITE; schachenallee 29; aarau ; SZ
• Manufacturer (Section G): AARAU SWITZERLAND MANUFACTURING SITE; schachenallee 29; aarau ; SZ
• Manufacturer Contact: connie mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 3878105
• MDR Text Key: 4596081
• Report Number: 1020279-2014-00373
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2014

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
• Device Catalogue Number: 75002699
• Device Lot Number: F1023101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 06/17/2014
• 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: 71303604, 71332754, 71335554
• Patient Age: 72 YR
• Patient Weight: 60