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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP METAL HEAD
Device Problem Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Osteolysis (2377); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/15/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Clinical symptoms code: appropriate term/code not available (b)(4) used to capture infections. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Literature article entitled, ¿pinnacle ultamet metal-on-metal total hip arthroplasty survivorship: average 10-year follow-up¿, published by arthroplasty today, was reviewed 12/28/2020. The purpose of this study was to do a retrospective review of mom tha completed by a single surgeon with a single implant between 2003 and 2008 was conducted. Patient demographics, implant data, radiographs, and revision details were collected at follow-up. Incidence rates for revision and osteolysis were calculated in regard to the femoral head size, stem offset, neck length, and cup abduction angles. Mom implant systems with longer necks and smaller cup abduction angles may lead to increased need for revision. Results from this study suggest a need for closer long-term follow-up of mom tha systems. The components used were depuy pinnacle ultamet acetabular cups, metal on metal articulation with the s-rom stem/sleeve. 692 tha were identified with 544 patient¿s returning for a median follow-up of 10. 3 years. The low overall rate of revision for this mom implant is reassuring for surgeons monitoring this patient population, particularly in the face of a potential difficult revision surgery, and serious postoperative complications. Lower cup abduction angles and longer neck lengths in mom implants may predict the need for revision surgery. It is important for surgeons to take into account the implant specifications when making a diagnosis of altr and deciding whether or not to proceed with revision. Mom implants continue to be a challenge, but the data presented here, combined with patient evaluation and radiologic and laboratory studies, can help guide the treatment of this population, leading to prudent decision-making regarding if and when these patients should be revised. There were 37 revision noted with in the 10 year follow-up. Reasons for revisions included: osteolysis, pseudotumor, altr, metal wear due to cup/neck impingement mechanically assisted crevice corrosion, component impingement, failed hardware, instability, and infection.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11132760
MDR Text Key233065073
Report Number1818910-2021-00624
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP METAL HEAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2021
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 Treatment Data
Date Received: 01/07/2021 Patient Sequence Number: 1
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