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

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

Revision surgery was performed due to pain and migration.

• Brand Name: COBALT CHROME BALL HEAD
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116
• MDR Report Key: 6511120
• MDR Text Key: 73372746
• Report Number: 1020279-2017-00287
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR