MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OTHER HIPS PRIMARY C; INTEGRAL BIPOLAR CUP SET 38MM

Catalog Number 11138

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 02/23/2015

Event Type  Injury  

Event Description

It was reported that a revision was performed due to dislocation/luxation.

Manufacturer Narrative

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.No further investigation is warranted at this time.(b)(4).

• Brand Name: OTHER HIPS PRIMARY C
• Type of Device: INTEGRAL BIPOLAR CUP SET 38MM
• 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: lisa hassell ; 1450 brooks road; memphis, TN 38116 ; 9013991128
• MDR Report Key: 4590673
• MDR Text Key: 18089369
• Report Number: 1020279-2015-00117
• 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: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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