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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD HIP ACETABULAR INSERT/LINER

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD HIP ACETABULAR INSERT/LINER Back to Search Results
Catalog Number 121887458
Device Problems Naturally Worn (2988); Insufficient Information (3190)
Patient Problems Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Depression (2361); No Code Available (3191)
Event Date 12/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
This complaint is under investigation. Depuy will notify the fda of the results of the investigation once it has been completed. (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
Patient claim received. Patient alleges he suffers from ions "creeping up" and pain. Update 11/14/2016 litigation received. Per depuy's complaint handling procedure, all litigation is reported. Complaint was updated 11/27/2016. Update may 12, 2017: legal medical records received. In addition to what was previously alleged, pfs alleges ringing in both ears, pain in lower back and in right bursa radiates down to right knee, cognitive issues with becoming forgetful, angry, depressed, lack of mobility, loss of range of motion and decreased desired activities. After review of medical records for the mdr reportability, a significant granulation tissue and bursal inflammation was noted in the revision notes. There was some fluid in the hip joint and some trunnionosis was also reported. Stem has been added due to trunnionosis. There was no evidence of metallosis or stem loosening. Cobalt-chromium levels were below 7ppb. Product codes and lot numbers were provided. This was updated on may 19, 2017.
 
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Brand NamePINNACLE MTL INS NEUT40IDX58OD
Type of DeviceHIP ACETABULAR INSERT/LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key6583909
MDR Text Key282378471
Report Number1818910-2017-18479
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
Type of Report Initial,Followup,Followup
Report Date 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/01/2013
Device Catalogue Number121887458
Device Lot Number2749431
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/23/2017 Patient Sequence Number: 1
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