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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. - 1818910 UNKNOWN DEPUY FEMORAL STEM; HIP FEMORAL STEM/SLEEVE

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DEPUY ORTHOPAEDICS, INC. - 1818910 UNKNOWN DEPUY FEMORAL STEM; HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number UNK-HIP
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
New etq record created in order to update etq (legacy system) complaint number wpc (b)(4).Reason for original complaint ¿ litigation papers allege the patient was injured by excessive levels of chromium and cobalt.Update: plaintiff fact sheet received with part/lot information.No new information was received that would change the investigational results.Update rec¿d 6/25/2014 - sales rep reported revision surgery.Patient was revised to address pain.The patient previously had a resurfacing head, which was revised on (b)(6) 2009.Information for the resurfacing head can be located on wpc (b)(4).There is no new additional information that would affect the investigation.This complaint was updated on: 07/17/14.Update rec¿d 11/18/2014 - medical records received.Upon revision, fluid, adverse local soft tissue reaction, and no bony ingrowth on the acetabular cup were noted.The stem and sleeve are being added to the complaint for elevated metal ion levels.The stem remained in situ.This complaint was updated on: 12/18/2014.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.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.
 
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Brand Name
UNKNOWN DEPUY FEMORAL STEM
Type of Device
HIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. - 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. - 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
steve dowell
700 orthopaedic drive
warsaw, IN 46581
5743714918
MDR Report Key4339053
MDR Text Key5215752
Report Number1818910-2014-34612
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Attorney
Remedial Action Other
Type of Report Initial
Report Date 11/18/2014
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 Physician
Device Catalogue NumberUNK-HIP
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/18/2014
Initial Date FDA Received12/18/2014
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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