MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 32MM X 48MM; R3 XLPE LINERS

Catalog Number 71337948

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

Udi #: (b)(4).Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

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

Manufacturer Narrative

The associated complaint device was not returned.

• Brand Name: R3 20 DEG +4 XLPE ACET LNR 32MM X 48MM
• Type of Device: R3 XLPE LINERS
• 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 ; 9013995009
• MDR Report Key: 5847684
• MDR Text Key: 51182102
• Report Number: 1020279-2016-00604
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113848
• 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: 07/19/2016

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: 71337948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2016
• 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