MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 36 0 LAT +4 54-56 F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333495
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right hip revision surgery was performed due to pain and high levels of cobalt and chromium.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.However according to the detail page the revision surgery was performed due to periprosthetic fracture after patient fall.No further clinical/medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.Credit cannot be issued for the device.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and based on the available information the reported instability and dislocation are presumably due to patient specific factors and/or the procedure technique to correct for the loose soft tissue.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: REF XLPE 36 0 LAT +4 54-56 F
• 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: 7578815
• Report Number: 1020279-2018-01080
• Device Sequence Number: 11420529
• Product Code: LPH
• UDI-Device Identifier: 03596010552945
• UDI-Public: 03596010552945
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/15/2019

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 Expiration Date: 12/23/2015
• Device Catalogue Number: 71333495
• Device Lot Number: 05MM01578
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 05/22/2018; 05/22/2018; 11/11/2019
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 10/05/2018; 04/15/2019; 11/15/2019
• 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; Required Intervention
• Patient Age: 75 YR