MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 PRIMARY 20 DEG XLPE ACET LNR 36MM X 54MM; HIP IMPLANT

Catalog Number 71335754

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 04/08/2015

Event Type  Injury  

Event Description

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

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.A review of the device history record was performed which confirmed no inconsistencies.(b)(4).

• Brand Name: R3 PRIMARY 20 DEG XLPE ACET LNR 36MM X 54MM
• Type of Device: HIP IMPLANT
• 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: connie mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 4695378
• MDR Text Key: 20726804
• Report Number: 1020279-2015-00197
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

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 Expiration Date: 04/01/2024
• Device Catalogue Number: 71335754
• Device Lot Number: 14DM09109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 04/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR