MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +8; PROSTHESIS, HIP,SEMI-, MTL/CERAMIC/POLYMER,CMNDORNON-POROUS, UNCMNTD

Model Number	71343208
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had smith&nephew products in place since (b)(6) 2013 and was feeling uncomfortable and loosening of the cup.Revision surgery was performed and the cup and inner head were explanted.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that it has been communicated that no clinical documents are available.Therefore, no thorough clinical assessment of the reported issue can be rendered.Should additional information be provided, the clinical/medical investigation task will be reopened.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include poor surgical technique or device selection.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.

• Brand Name: OXINIUM FEM HD 12/14 32MM +8
• Common Device Name: PROSTHESIS, HIP,SEMI-, MTL/CERAMIC/POLYMER,CMNDORNON-POROUS, UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9528903
• Report Number: 1020279-2019-04621
• Device Sequence Number: 2246038
• Product Code: LZO
• UDI-Device Identifier: 03596010474230
• UDI-Public: 03596010474230
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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 Model Number: 71343208
• Device Catalogue Number: 71343208
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 04/23/2020
• 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: Required Intervention