MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 02/01/2018

Event Type  Injury  

Event Description

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

Manufacturer Narrative

The associated complaint device was not returned for evaluation.No clinical supporting documents were provided to conduct a thorough analysis of the reported issue.No medical assessment can be rendered.Without the return of the actual product involved and the product information available, our investigation of this report is inconclusive.No further actions are being taken at this time.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7354847
• MDR Text Key: 102951410
• Report Number: 1020279-2018-00358
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: LG
• 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: 06/03/2018

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?: Yes
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention