• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY PINNACLE METAL LINER HIP ACETABULAR INSERT/LINER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY PINNACLE METAL LINER HIP ACETABULAR INSERT/LINER Back to Search Results
Catalog Number 121887354
Device Problems Insufficient Information (3190); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Swelling (2091); Discomfort (2330)
Event Date 08/25/2016
Event Type  Injury  
Manufacturer Narrative
Udi: (b)(4).
 
Manufacturer Narrative
This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time. A follow-up medwatch will be filed as appropriate. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Litigation states patient was revised to address pain, discomfort and swelling.
 
Manufacturer Narrative
Examination of the reported devices was not possible as they were not returned. A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided. The investigation can draw no conclusion regarding the reported event with the information available. Based on the inability to determine root cause, the need for corrective action has not been indicated. 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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Update ((b)(4)) pfs and medical records received. Pfs alleges pain, elevated levels of chromium and cobalt and struggled with occasional limited mobility. It was also stated that there was a crunching sound in left hip. No laboratory values provided. The complaint was updated on apr 28, 2017.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN DEPUY PINNACLE METAL LINER
Type of DeviceHIP ACETABULAR INSERT/LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581-0988
5743725905
MDR Report Key6270859
MDR Text Key132638219
Report Number1818910-2017-11230
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 consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/01/2011
Device Catalogue Number121887354
Device Lot Number2138003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2019
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: 01/23/2017 Patient Sequence Number: 1
-
-