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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 ALTRX +4 10D 32IDX50OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC 1818910 ALTRX +4 10D 32IDX50OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 122132150
Device Problem Disassembly
Event Date 05/22/2018
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

Der states that the patient had total hip on (b)(6) 2016. Xray¿s appeared normal until last visit. The patient had increased pain and hip began to squeak. Liner appeared to be disassociated from cup. Patient was brought to surgery and the liner was disassociated. New liner was implanted and new head was implanted. Doi: (b)(6) 2016; dor: (b)(6) 2018; right hip.

 
Manufacturer Narrative

Additional 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. 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 NameALTRX +4 10D 32IDX50OD
Type of DevicePINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46582-0988
5743725905
MDR Report Key7609622
Report Number1818910-2018-62423
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number122132150
Device LOT Number653632
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/04/2015
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: 06/18/2018 Patient Sequence Number: 1
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