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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887458
Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Test Result (2695); Not Applicable (3189); No Code Available (3191)
Event Date 06/03/2016
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pinnacle litigation records received.Litigation alleges severe pain, discomfort and tested metal ions well above an acceptable range.Patient underwent a painful, complex and risky surgery to removed the device.During the revision, an extended trochanteric osteotomy was preformed.On (b)(6) 2016 the patient succumbed due in part from complications of the revision surgery.Doi: (b)(6) 2009 : dor: (b)(6) 2016; (right hip).Deceased patient.
 
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 device history record (dhr) review, was not possible because the required lot code(s) was not provided.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Ppf alleged metal wear and metallosis.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added no code available to capture medical device removal.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 : null device history batch : null device history review : null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
PINNACLE MTL INS NEUT40IDX58OD
Type of Device
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7590651
MDR Text Key110714852
Report Number1818910-2018-61836
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K062426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup
Report Date 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2013
Device Catalogue Number121887458
Device Lot Number2548857
Was Device Available for Evaluation? No
Date Manufacturer Received05/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
Patient Age75 YR
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