MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 32 20 DEG 58-60 G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71333336
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery, performed due to dislocation of hip 3 times.Liner and head were removed.
Additional Manufacturer Narrative
It was reported a revision surgery was performed due to dislocation.The associated oxinium head and acetabular liner, used in treatment, were returned and evaluated.A lab analysis was conducted and noted the liner does not display the presence of any abnormal wear of the id surface.Gouges and marks observed on the liner could be resulting from the stated dislocation or during the removal.One area of the lip exhibits some deformation that might indicate an impingement with the femoral neck.Noted faint outlines of apex and screw hole patterns from the shell are observed.The head noted some gouges on the articular surface, this markings most likely occurred during dislocations.The examination revealed the presence of titanium material with the gouged area.This clearly indicates the head came into contact with the shell which is not returned.The lower flat face of the head showed some cuts and gouges.Iron found around that area.The presence of iron indicates the markings on the lower flat of the head were caused by contact with a stainless steel instruments during removal.No deviations to manufacturing process noted for the listed batches and no prior complaints history found for the listed parts for the listed failure mode.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship between the devices and the reported incident could not be corroborated.A review of instructions for use revealed the alleged failure has been identified in the possible adverse events.Probable causes could include but not limited to patient anatomy or surgical technique.No medical documents were received, thus no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REF XLPE 32 20 DEG 58-60 G
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9164265
• Report Number: 1020279-2019-03580
• Device Sequence Number: 19276678
• Product Code: LPH
• UDI-Device Identifier: 03596010455697
• UDI-Public: 03596010455697
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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 Expiration Date: 01/28/2014
• Device Model Number: 71333336
• Device Catalogue Number: 71333336
• Device Lot Number: 04AM02300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 02/05/2020
• 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; Required Intervention