MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TOTAL HIP REPLACEMENT PROSTHESIS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Device Problem Nonstandard Device (1420)

Patient Problems Death (1802); Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544)

Event Date 02/04/2016

Event Type  Death  

Event Description

A reporter called to report about her husband who died in 2016 two years later after he had hip replacements.The reporter claimed her husband had received a left and right hip replacements once the devices have been recalled.She said he had the left hip implant in (b)(6) of 2012 from biomet and the right one in (b)(6) of 2014 from smith and nephew.She said her husband suffered from a lot of pain, was not able to walk, did not have an appetite, he was falling a lot, his whole body changed color to black.She also said after he had the right hip implant, he came back home from the hospital with an infection.

• Brand Name: TOTAL HIP REPLACEMENT PROSTHESIS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 10250683
• MDR Text Key: 198379671
• Report Number: MW5095452
• Device Sequence Number: 2
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/08/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR