MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 26 20 DEG 46-48 D; TEST, ERYTHROCYTE SEDIMENTATION RATE

Catalog Number 71333313

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 02/01/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to the wearing.

Manufacturer Narrative

The associated reflection acetabular liner was not returned for evaluation.Without the explant or the requested clinical information, the root cause of the wear cannot be concluded.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.Without the return of the actual product involved and no batch information available, our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: REF XLPE 26 20 DEG 46-48 D
• Type of Device: TEST, ERYTHROCYTE SEDIMENTATION RATE
• 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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7336536
• MDR Text Key: 102301564
• Report Number: 1020279-2018-00313
• Device Sequence Number: 1
• Product Code: JPH
• UDI-Device Identifier: 03596010455567
• UDI-Public: 03596010455567
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002747
• 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: 04/17/2018

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: 71333313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: No
• 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