MAUDE Adverse Event Report: ZIMMER ZIMMER M/L TAPER HIP HEAD

Catalog Number REF 8018-32-01

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Toxicity (2333); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)

Event Date 08/01/2015

Event Type  Injury  

Event Description

I had a hip replaced (b)(6) 2010.The hip began to really bother in (b)(6) 2015.I went to the physician in (b)(6) 2015 and had x-ray and blood work.Cobalt at that time was 1.5ug/l normal 9ug/l.As the pain increased significantly and mobility became more limited, i went to my doctor in (b)(6) and he put me on prednisone which helped for a short period of time.I had to return to my surgeon's office (b)(6) 2016 as the excruciating pain and significant loss of mobility.I received a shot of cortisone and blood work.My cobalt level by then had risen to 4.8ug/l.The pain was unbearable and i was sent for a mri.I had to schedule the mri twice and had to abort both times as the pain was so severe.Revision surgery was scheduled for (b)(6) 2016 which has brought relief.The poison from the zimmer head was removed.This particular head has not been recalled at this time.No person should have to go through the excruciating pain and suffering i went through for over a year!!!.

• Brand Name: ZIMMER M/L TAPER HIP HEAD
• Type of Device: ZIMMER M/L TAPER HIP HEAD
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 6242907
• MDR Text Key: 64682403
• Report Number: MW5067172
• Device Sequence Number: 1
• Product Code: LPH
• 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: 01/09/2017

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: REF 8018-32-01
• Device Lot Number: 61647975
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 1 BABY ASPIRIN/DAY.; OTC MEDS: NONE; RX MEDS: 20MG LIPITOR
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 98