MAUDE Adverse Event Report: ZIMMER ZIMMER NEXGEN LPS

Lot Number 61425092, 61080014, 61319942

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 03/08/2010

Event Type  Injury  

Event Description

Reporter states that on (b)(6)2010 he had surgery to have the zimmer nexgen lps device implanted.After the surgery he has experienced extreme pain and difficulty walking.He has had 2 revision surgeries one in (b)(6) 2012, and one in (b)(6) 2013.In (b)(6) 2014, he went to a new physician who told him that they need to remove the device and replace it with a "stryker one." after having the stryker device in place he no longer has any issues.He is currently planning to pursue legal action against zimmer.(b)(6).

• Brand Name: ZIMMER NEXGEN LPS
• Type of Device: ZIMMER NEXGEN LPS
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 6108934
• MDR Text Key: 60312027
• Report Number: MW5066090
• Device Sequence Number: 1
• Product Code: OIY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 61425092, 61080014, 61319942
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR