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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PINNACLE MULTIHOLE II CUP 60MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS, INC. PINNACLE MULTIHOLE II CUP 60MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121720060
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Weakness (2145); Heart Failure (2206); Discomfort (2330); Injury (2348); Respiratory Failure (2484); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671)
Event Date 04/06/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Complaint description: patient email: (b)(6) is my husband and he received a depuy prosthesis on (b)(6) 2007 at (b)(6) medical center. Since last year he has suffered great pain and inability to walk and has been confined to bed due to a huge growth on his right thigh from metal from the prosthesis. This required three hospitalizations, two biopsies and one surgery to remove the growth and implant a temporary prosthesis. Now he needs a permanent prosthesis immediately which is made especially for him because the growth ate part of his pelvic bone and thigh muscle. His suffering and mine have been great. We are asking for (b)(6) to settle out of court and (b)(6) in court and an immediate payment to cover the cost of the prosthesis. Please, respond immediately and remember the suffering is intense. After loosening of prosthesis his wife asks us for compensation. Update (b)(6) 20 jun 2018: (b)(4) has been re-opened under (b)(4) due the litigation records received. Litigation alleges respiratory failure, pain, sleeping and walking difficulty, friction and wear between chromium and cobalt metal liner and head, toxic metal ions in blood, tissue, bone and elevated metal ions, resulting discomfort, hips weak, swelling, tense formation, weight loss, loss of mobility, loss range of motion, injury and mental anguish. On (b)(6) 2015 surgeon performed surgery to relieve pain and discomfort, found to have a tumor had formed and took it for biopsy. On (b)(6) 2015 second biopsy done. On (b)(6) 2016 explanted pinnacle and have it replaced temporary prosthesis implant. On (b)(6) 2016 another temporary prosthesis was implanted, permanent not done due to a serious infection. On (b)(6) 2016 permanent replacement was to be implanted, however, plaintiff condition deteriorated, necessitating hospice care. On (b)(6) 2016 patient died due to acute cardiovascular and respiratory insufficiency as a direct result of complications from multiple surgeries. Added law firm name, lawyer name. Updated dor and patient harm of the ip's. Doi: (b)(6) 2007; dor: (b)(6) 2016; right hip.
 
Manufacturer Narrative
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. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Udi: (b)(4).
 
Event Description
Update ad 11 sep 2018: corrected patient code for swelling and metallosis.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand NamePINNACLE MULTIHOLE II CUP 60MM
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6103142063
MDR Report Key7689601
MDR Text Key114029468
Report Number1818910-2018-64452
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Caregivers
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2012
Device Catalogue Number121720060
Device Lot NumberZP8DA1000
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 Received11/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2005
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: 07/16/2018 Patient Sequence Number: 1
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