MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTEGRAL BIPOLAR CUP SET 38MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 11138

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 09/18/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to migration.No further information is available.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, although revision due to migration was reported, no supporting documentation was provided.A thorough medical investigation could not be performed.The patient impact beyond the revision, possible pain/discomfort and an expected post-op rehabilitation phase cannot be determined.No further medical assessment is warranted at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: INTEGRAL BIPOLAR CUP SET 38MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8028277
• MDR Text Key: 125786272
• Report Number: 1020279-2018-02318
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

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: 11138
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 10/14/2018
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention