MAUDE Adverse Event Report: DEPUY MSPEC METAL FEMORAL HEAD

Lot Number 3575391

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 02/10/2012

Event Type  Injury  

Event Description

My mother had a partial r hip replacement 2 years ago and have had pain and suffering ever since.The length of the leg was off so she was very unstable and had limping.In (b)(6) 2013 the dr.Took out the partial and put in a full replacement to decrease the pain.That didn't work because it kept popping out.In (b)(6) 2014 she had a revision to stabalize the hip.The femoral head and liner was removed and the articuleze head was implanted.Since (b)(6).She had developed multiple nodules that started in her r hip.Moved down her leg to the calf and now over to her other leg.The dermatologist dx it as "organized foreign body reaction".The doctor seems insensitive and i am afraid my mother will lose her leg.These nodules have taken over her body.She is afraid of losing her leg also.Total hip replacement implanted (b)(6) 2013 explanted (b)(6) 2014 pinnacle porocoat acetabular shell sector 2 lot 445100 /exp.10/01/2013, pinnacle bone screw cancellous lot d12082471, exp 07/01/2013.Pinnacle altrx polyethylene acetabular liner lot 446026, exp.11/01/2018.M/spec metal femoral head lot 3575391 exp.02/01/2018.Revision of hip implanted (b)(6) 2014.Pinnacle gvf polyethylene constrained acetabular liner lot fb3ft1 xp 01/01/2016, articuleze femoral head lot d13021093 exp.01/01/2018.

• Brand Name: MSPEC METAL FEMORAL HEAD
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): DEPUY
• MDR Report Key: 4092935
• MDR Text Key: 4741426
• Report Number: MW5038167
• Device Sequence Number: 4
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2014
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/01/2018
• Device Lot Number: 3575391
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 68