MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544); Physical Asymmetry (4573)

Event Date 08/24/2009

Event Type  Injury  

Event Description

Patient initiated complaint: the patient stated, "i am really frustrated with the quality of my life.As a result of my hip replacement initially done in 1990.Revision done in 1997.And another revision done on (b)(6) 2009.My initial hip replacement conducted in 1990.I developed a metal allergy.And unsure of whatever reason it was determined it had to be replaced.The second hip which i thought was done in 1999.Dr has it documented that it was done in 1997.(but i later found he changed some documents to cover up his negligence).This second hip revision i was told by the dr (b)(6).He stated it was to be the best revision.It was not.After a few years i had parts of the revision coming apart.Later developed a cyst of these particles forming a ball next to my hip.Everyone commented on my walking.I developed an infection which i had for 3 years.That my doctor never told me.Dr.Of group health in (b)(6).I was told it needed to be replaced.But dr (b)(6) never followed up with me.Until my hip collapsed.Was on pain pills for a couple years prior to the hip failure.When i was in surgery room to get a revision he shared with me that he had told me of infection.He had not.He had no bedside manners.Talked down to you.Thought he was god.And realized i fell thru the cracks.Which he tried to cover up his neglect.This third revision was the hardest.I didn't go back to work until the 11th week following surgery.I was in a great deal of pain.And didn't drive a vehicle for 6 months after surgery.I quit my job due to medical complications.Which i had problems sitting 8 hours a day.Had leg swelling which at that time we couldn't determine why.Since i no longer had job.I was walking more.Thus i realized that walking was causing me back pain.I have been on pain pills since 2012.Due to this condition.I knew the walking was causing me the back pain.And i knew it was a result of my hip.I have every year went to doctors.Who don't want to acknowledge my hip is the issue.But physical therapy every time stated my hip was tye cause of my back pain.I am tired of fighting this battle with doctors.With my insistence i finally got a doctor in 2018 that stated i had a fracture around the hip.But it was healed.But he and another made light of it.They finally also concluded that my one leg is shorter than the other.The end result now is my back has bone on bone disc issues to the right side.(which is where i had all 3 revisions).I wake up to pain everyday.If i stay off my feet in my bed.No pain.I can't even drive a car now without pain.This is all because doctors are afraid to acknowledge issues.Because they don't want to be involved in a lawsuit.These revisions and issues from these hip products have caused me so many issues throughout the years.And now it has ruined my back.And other medical issues.Your company or whomever needs to follow up with patients.Monitor patients.When you know that a product has issues.There needs to be follow up with a patient.Since apparently doctors don't do it.As the hmos don't want to spend the money.Or recognize issues as they are afraid of being involved in a lawsuit.All i wanted from the beginning is relief from pain.They want to do back surgery.And my response to this.Is why have the surgery.When i will have the same issue with hip.Since no one wants to recognize this as the issue.The leg shortness is a common sense answer.As one leg being shorter affects your whole core of your body.So why have the back surgery.In addition evidently i had a hip issue.If it shows i had a fracture.But now it's healed.Come on people.Wake up.My faith in the medical community, in your products and doctors is very low.Which makes a person just want to give up." doi: 1997/1999 (date discrepancy) dor: (b)(6) 2009 affected side: right hip.This complaint is linked to (b)(4) which the patient currently reports pain, leg length discrepancy, walking issues, back and neck pain.(b)(4) captures doi: (b)(6) 1990 dor: 1997 or 1999 (date discrepancy) which the patient was revised due to unknown reasons.The patient noted that they had a metal allergy.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13357658
• MDR Text Key: 289187293
• Report Number: 1818910-2022-01653
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 01/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR HOLE ELIMINATOR; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention