MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 22 MM +8; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	71342208
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this is 3rd revision of hip (previous product experience).Patient dislocated hip.
Additional Manufacturer Narrative
A dislocation/ luxation was reported with a polarcup xlpe insert 22/43.The device in question was not sent back for investigation and a product evaluation could not be conducted.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported failure mode.A review of the complaint history revealed no other complaints for the batch in question.One other complaint with similar issue has been reported for the device.No supporting clinical documents were provided to conduct a thorough medical investigation.Therefore based on insufficient information, a thorough clinical assessment could not be performed.The stated failure mode could not be confirmed.The root cause of reported dislocation/ luxation cannot clearly be reproduced and stays undetermined.Based on available information the need for corrective action is not indicated.The complaint will be reopened should additional information be received.Smith and nephew will continue to monitor this device for similar issues.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the oxinium femoral head (71342208) was not investigated as it is a polarcup luxation (i.E.Between insert and shell and not insert and ball head) and could not have contributed to the reported failure mode, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.The polarcup xlpe insert 22/43 event has been reported in mdr 1020279-2019-01210.

• Brand Name: OXINIUM FEM HD 12/14 22 MM +8
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8453225
• Report Number: 1020279-2019-01209
• Device Sequence Number: 2639819
• Product Code: LZO
• UDI-Device Identifier: 03596010488886
• UDI-Public: 03596010488886
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2019

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: 05/26/2025
• Device Catalogue Number: 71342208
• Device Lot Number: 15EM19894
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019; 06/13/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/07/2019; 06/18/2019
• 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