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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-22-052
Device Problems Use of Device Problem (1670); Malposition of Device (2616)
Patient Problems Edema (1820); Fall (1848); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Distress (2329); Numbness (2415); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/05/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).A follow up will be conducted to provide the legal plaintiff information for the initial reporter once the details are provided.Initial reporter occupation: lawyer.(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
It was reported that there was metal on metal revision.Zimmer cup implanted with new head.After review of the medical records the patient was revised to address the failed left hip replacement and adverse metal reaction.Revision note reported of a large brown fluid collection and excessive combine anteversion with mild posterior femoral neck notching and mild taper corrosion.The acetabulum showed some ischial osteolysis.Mri reported of joint effusion with synovitis.Laboratory results for cobalt and chromium level showed above normal.The reported unknown cup, liner, and head from the ips were updated and added stem to capture the elevated metal ions and corrosion.The reported right side of the hip was changed to left side hip.Right hip was captured under (b)(4).Doi: unknown.Dor: (b)(6) 2019; right hip.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Patient alleges that a particulate debris from pinnacle devices causes severe inflammation, severe pain, tissue and bone loss and other related diseases.The known friction wear is believed to have caused amounts of toxic cobalt-chromium metal debris to be released into patient's tissue surrounding the implants.Mri had findings of adverse local tissue reaction.Patient alleges physical, mental, and emotional injuries.Patient experienced and will experience limited to partial or complete loss of mobility, loss of range of motion, mental anguish, and diminished enjoyment of life.Doi: (b)(6) 2009.Dor: (b)(6) 2019.(left hip).
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 clinical code: appropriate term / code not available (e2402) is used to capture bone injury (e20).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.E3.Initial reporter occupation: lawyer.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  h6 clinical code: appropriate term/ code not available (e2402) is used to capture blood heavy metal increased.Unspecified tissue injury (e2015) is used to capture soft tissue injury and bone injury.Unspecified musculoskeletal problem (e1635) is used to capture joint injury and joint disorder.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Ppf alleges abductor muscle repair and pseudotumor.Revision notes stated posterior neck on rim impingement with minimal hip hyperextension and external rotation and decided to revise the cup.Cup, head, and liner were removed.Patient had left hip clicking and slipping.Patient experienced numbness in lower legs and feet due to metallosis, cannot lift feet when walking.During revision, the surgeon stated that there are more fluid and damage than expected.Patient fell in apr 2021 and had fractured femur due to difficulty in walking, and nerve pain is much morse at night when lay down.Fluid could reflect a small partial thickness tear, pseudocapsular thickening.Doi: (b)(6) 2009, dor: (b)(6) 2019, (left hip).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
PINNACLE SECTOR II CUP 52MM
Type of Device
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC 1818910
700 orthopaedic drive
suzhou industrial park
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10465563
MDR Text Key204720210
Report Number1818910-2020-18979
Device Sequence Number1
Product Code KWA
UDI-Device Identifier10603295009825
UDI-Public10603295009825
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 Other,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1217-22-052
Device Catalogue Number121722052
Device Lot NumberD5SBA1000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ARTICULEZE M HEAD 36MM +5; PINNACLE MTL INS NEUT36IDX52OD; SUMMIT POR TAPER SZ4 STD OFF; ARTICULEZE M HEAD 36MM +5; PINNACLE MTL INS NEUT36IDX52OD; SUMMIT POR TAPER SZ4 STD OFF
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient SexFemale
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