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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +0; HIP FEMORAL HEAD
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DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +0; HIP FEMORAL HEAD Back to Search Results
Catalog Number 136531000
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Skin Irritation (2076); Swelling (2091); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)
Event Date 09/06/2017
Event Type  Injury  
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
On (b)(6) 2017: litigation received.Litigation alleges physical and mental pain and suffering and debility.There is no report of revision at this time.
 
Manufacturer Narrative
No device associated with this report was received for examination.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
(b)(4).
 
Event Description
Pfs alleges discomfort, swelling, trouble with stairs, sleeping, sitting or standing for long periods of time.
 
Manufacturer Narrative
(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.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: sep 6, 2017: litigation received.Litigation alleges physical and mental pain and suffering and debility.There is no report of revision at this time.Update nov 7, 2017: medical records received.In addition to what was previously alleged, pfs alleges discomfort, swelling, trouble with stairs, sleeping, sitting or standing for long periods of time.After review of the medical records, product codes and lot numbers were provided.This complaint was updated on nov 10, 2017.
 
Manufacturer Narrative
(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
S-ROM M HEAD 36MM +0
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key6918114
MDR Text Key88393737
Report Number1818910-2017-25966
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K120599
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/27/2013
Device Catalogue Number136531000
Device Lot Number2587496
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/06/2017
Initial Date FDA Received10/05/2017
Supplement Dates Manufacturer Received11/01/2017
11/07/2017
07/20/2018
12/28/2018
Supplement Dates FDA Received11/06/2017
11/20/2017
08/16/2018
01/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient Weight77
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