MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS STRYKER ACCOLADE HIP STEM TMZF; PROSTHESIS, HIP, SEMI - CONSTRAINED ,UNCEMENTED

Catalog Number 6020-4565

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

Patient Problems Myocardial Infarction (1969); Pain (1994); Toxicity (2333)

Event Date 07/07/2013

Event Type  Injury  

Event Description

I had a total hip replacement (b)(6) 2008.The implants were stryker cormet cup 5/54mm, lot # lhr1, cat# /serial # (b)(4); stryker accolate tmzf hip stem 4.5, lot / batch# 25387501, catalog / serial # (b)(4); stryker 5/46mm -4mm unipolar head (one professional told me that was really a bi-polar head, i'm taking the info from the digital implant report.) lot #/ batch # lkjs, cat # / serial # (b)(4); #4 v-40 c-taper adapter sleeve,lot # / batch # 35937604, cat # / serial # (b)(4).Serious problems started in (b)(6) 2013.My surgeon dr (b)(6), told me for 4 years my hip was fine, my pain had to be from my back which he said had inoperable arthritis.Dr (b)(6) retired in 2018, so i saw a different orthopedic surgeon.He immediately recognized the symptoms and ordered the proper, necessary tests to confirm the diagnosis of faulty.Failed hip, large pseudotumor, high levels of chromium and cobalt in the blood serum.I was in excruciating pain for years and suffered numerous health problems including an unexplained heart attack (b)(6) 2017.I had hip replacement revision surgery (b)(6) 2018.My surgeon was dr (b)(6).Large pseudo tumor on hip, metallosis from severe cobalt and chromium poisoning which led to a host of health problems including a heart attack.

Event Description

Add'l info received on 04/16/2019 from reporter for report number mw5085656.Pt states her digital implant sheet describes her implant as a "unipolar head" which is used for hemi-arthroplasties, yet she had a total hip implant.She is worried that the wrong implant might have been used in her procedure.She also believes this device was recalled while still implanted.She has since had a revision, which she mentioned in her initial report, however she is still awaiting on the analysis from the mfr.

Event Description

Add'l info received from reporter on 04/24/2019 for mw5085656: pt states that she received a call from stryker yesterday regarding the femoral head implanted, stating that the head was manufactured by corin in the (b)(4) and that stryker was simply the distributor.Pt goes on to state that the corin has had lawsuits prior regarding their hip products.

• Brand Name: STRYKER ACCOLADE HIP STEM TMZF
• Type of Device: PROSTHESIS, HIP, SEMI - CONSTRAINED ,UNCEMENTED
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
• MDR Report Key: 8496289
• MDR Text Key: 141459394
• Report Number: MW5085656
• Device Sequence Number: 3
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6020-4565
• Device Lot Number: 25387501
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 70 YR
• Patient Weight: 54