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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Corroded (1131); Material Disintegration (1177); Noise, Audible (3273)
Patient Problems Edema (1820); Inflammation (1932); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
Event Date 01/25/2011
Event Type  Injury  
Manufacturer Narrative
(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
Ppf and medical records received. Ppf has no allegation. After review of medical records, the patient was revised for failed left total hip with severe pain. Operative notes reported moderated amount of milky-appearing fluid, chronic inflammation, metal debris, and there was significant burnishing of the femoral head and liner. The acetabular component was not loose but it was noted to be in marked retroversion. Doi: unknown; dor: (b)(6) 2011; left hip.
 
Manufacturer Narrative
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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).
 
Event Description
Pfs alleges discomfort, lack of mobility, emotional distress, difficulty walking and popping/clicking. After review of medical records, the patient was revised to address left total hip arthroplasty. Revision note reported pain; and was stated that the cloudy fluid was due to metal debris and chronic inflammation related to that and did not feel that this represented chronic infection and the acetabular component was not loose but it was noted to be in marked retroversion.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key9314900
MDR Text Key169915677
Report Number1818910-2019-115877
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,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received12/03/2019
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: 11/13/2019 Patient Sequence Number: 1
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