MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. REF XLPE 28 20 DEG 54-56 F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333325
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the liner could not be locked, finally a backup device was used to complete the surgery.
Additional Manufacturer Narrative
The associated reflection xlpe liner was returned and evaluated.An inspection of the product noted that scratches are observed at the dovetails, causing by attempt implantation.Dimensional inspection was performed and the failure mode cannot be confirmed.The damage/deformation at one location of the device would not allow for accurate measurement.The complaint device was also attempted to be implanted, which may or may not have altered the dimensional characteristics.All other associated features were measured within tolerance.The device was manufactured in 2014.Our investigation included a review of complaint history for the listed part which revealed no prior complaints for the listed failure mode.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.We consider this investigation closed.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
The associated reflection xlpe liner was returned and evaluated.An inspection of the product noted that scratches are observed at the dovetails, causing by attempt implantation.Dimensional inspection was performed and the failure mode cannot be confirmed.The damage/deformation at one location of the device would not allow for accurate measurement.The complaint device was also attempted to be implanted, which may or may not have altered the dimensional characteristics.All other associated features were measured within tolerance.The device was manufactured in 2014.Our investigation included a review of complaint history for the listed part which revealed no prior complaints for the listed failure mode.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: REF XLPE 28 20 DEG 54-56 F
• 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: 7820720
• Report Number: 1020279-2018-01649
• Device Sequence Number: 14037419
• Product Code: LPH
• UDI-Device Identifier: 03596010455628
• UDI-Public: 03596010455628
• Combination Product (Y/N): N
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2024
• Device Catalogue Number: 71333325
• Device Lot Number: 14BM08504
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/30/2018
• 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: Hospitalization