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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 10D 32IDX50OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 121932150
Device Problem Disassembly
Event Date 01/01/2018
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

While handling an hip dislocation, the head dislocated from the insert. A radiography was performed and the images showed that the head was in contact with the cup. Due to the event, a revision surgery was performed.

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary: no information received with this individual complaint indicated that a broader investigation or corrective action was necessary. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. Device history lot: hj4170. Device history batch: null. Device history review: no anomalies or deviations were found. 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.

 
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Brand NamePINN MAR +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 Key7641268
Report Number1818910-2018-63289
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121932150
Device LOT NumberHJ4170
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 Received08/09/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/30/2017
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: 06/27/2018 Patient Sequence Number: 1
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