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

Catalog Number	71333313
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the wearing.
Additional 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
• Common Device Name: TEST, ERYTHROCYTE SEDIMENTATION RATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7336536
• Report Number: 1020279-2018-00313
• Device Sequence Number: 19131919
• Product Code: JPH
• UDI-Device Identifier: 03596010455567
• UDI-Public: 03596010455567
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 71333313
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention