MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +8; PRSTHSS,HIP,SM-CNSTRND,MTL/CRMC/PLYMR,CMNTD OR NN-PRS, UNCMNTD

Catalog Number	71342808
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed because patient had subluxed a number of times following surgery 3 months ago and dislocated for the first time when transferring onto surgical table yesterday.Doctor opened the hip joint using the previous incision.The head and liner were removed and a 20 degree trial liner used to assess stability.Surgeon still thought the joint was not sufficiently stable so progressed to removing the cup with explant.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of complaint history for the listed parts revealed no prior complaints for this failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.No medical documents were received for investigation.Therefore no medical assessment can be performed.Without the actual product involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 28MM +8
• Common Device Name: PRSTHSS,HIP,SM-CNSTRND,MTL/CRMC/PLYMR,CMNTD OR NN-PRS, UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7697383
• Report Number: 1020279-2018-01315
• Device Sequence Number: 1065581
• Product Code: LZO
• UDI-Device Identifier: 03596010474179
• UDI-Public: 03596010474179
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/07/2018

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: 03/01/2024
• Device Catalogue Number: 71342808
• Device Lot Number: 14CM01309
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention