MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF STEM WITH STIKTITE SZ 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71352501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the shell was put in too vertical.Doctors plan was to remove the shell and liner but when he found out the stem was a modular stem he decided to explant everything.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, the x-ray provided confirmed the complaint description of the angle of the cup but without comparisons its not known if this was a migration or the implant angle.Without the explant, the requested clinical information , or the reason for the revision, a root cause for the unspecified post operative condition cannot be concluded.The future impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.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.

• Brand Name: SMF STEM WITH STIKTITE SZ 1
• 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: 7451702
• Report Number: 1020279-2018-00797
• Device Sequence Number: 13484723
• Product Code: LPH
• UDI-Device Identifier: 03596010619570
• UDI-Public: 03596010619570
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K080625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2018

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 Catalogue Number: 71352501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 03/29/2018; 03/29/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/11/2018; 06/25/2018
• 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: 62 YR