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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 UNKNOWN HIP ACETABULAR LINERS

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DEPUY ORTHOPAEDIC INC, 1818910 UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Anxiety (2328); Distress (2329); Injury (2348); Depression (2361); Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pinnacle litigation received. Litigation alleges elevated metal ion levels, pain, injury, stress, emotional distress, mental anguish, grief, depression, and anxiety. Doi: (b)(6) 2009; dor: not revised; right 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 will be filed as appropriate.
 
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 will be filed as appropriate.
 
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 will be filed as appropriate.
 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7510355
MDR Text Key108107172
Report Number1818910-2018-59493
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 consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
Device Lot NumberUNKNOWN
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 Received09/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/14/2018 Patient Sequence Number: 1
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