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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL METAL FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD METAL
Device Problem Naturally Worn (2988)
Patient Problems Pain (1994); Distress (2329); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/03/2011
Event Type  Injury  
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.
 
Event Description
Pinnacle litigation records received. Litigation records alleges pain, injury, emotional distress, tissue and bone destruction, wear and excessive amounts of cobalt and chromium. Doi: 2005. Dor: (b)(6) 2011, left hip. Please see (b)(4) right hip.
 
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Brand NameUNK HIP FEMORAL HEAD METAL
Type of DeviceMETAL 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 dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key11681608
MDR Text Key245905657
Report Number1818910-2021-08157
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD METAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/16/2021 Patient Sequence Number: 1
Treatment
UNK HIP ACETABULAR LINER METAL PINNACLE; UNKNOWN HIP FEMORAL STEM
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