MAUDE Adverse Event Report: WRIGHT MEDICAL MOM HIP REPLACEMENT

Model Number LINEAGE 7020-3252

Device Problem Metal Shedding Debris (1804)

Patient Problems Fall (1848); Hearing Impairment (1881); Muscle Weakness (1967); Pain (1994); Blurred Vision (2137); Myalgia (2238); Arthralgia (2355); Confusion/ Disorientation (2553); Test Result (2695)

Event Type  Injury  

Event Description

I had a wright medical mon right hip replacement in (b)(6) 2002.Since the surgery, i have experienced right hip pain and was told that happens in about 5% of hip replacement cases.I accepted this explanation and got on with my life just dealing with the pain day-to-day.Over the past 5+ years i have developed a bizarre constellation of symptoms that include severe nearly global arthralgias and myalgias, ataxia, falls (at least 3 times with no injuries beyond "road rash"), hearing difficulty, visual fuzziness, confusion and last but not least gi and gu problems.Recently i noticed something online about mom hip replacement problems.My doctor agreed to do cobalt / chromium levels and they were quite high.I was actually relieved to find the labs were abnormal as it explained my symptoms.

• Brand Name: MOM HIP REPLACEMENT
• Type of Device: HIP REPLACEMENT
• Manufacturer (Section D): WRIGHT MEDICAL
• MDR Report Key: 4037630
• MDR Text Key: 4722058
• Report Number: MW5037897
• Device Sequence Number: 1
• Product Code: LZO
• 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: 08/20/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: LINEAGE 7020-3252
• Device Lot Number: 08210354
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 86