MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. REF LNR 26X 50-52 20 DG SZ E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71742650
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that due to wear of liner, revision surgery was performed.
Additional Manufacturer Narrative
The affected reflection acetabular liner was not returned for evaluation.It was reported that the surgeon performed a revision surgery due to wear.The device was manufactured in 2001.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that no clinical relevant documents, radiolographs were provided to conduct a thorough medical assessment.Thus, no medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.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.Credit cannot be issued for this device.

• Brand Name: REF LNR 26X 50-52 20 DG SZ E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7799819
• Report Number: 1020279-2018-01552
• Device Sequence Number: 2365343
• Product Code: LPH
• UDI-Device Identifier: 03596010232199
• UDI-Public: 03596010232199
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K932755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• 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): 03/13/2019

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: 71742650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 03/13/2019
• 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: Hospitalization
• Patient Age: 70 YR