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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 32IDX48OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 32IDX48OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 122132148
Device Problems Disassembly; Fracture
Event Date 05/18/2018
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 poly became disassociated and fractured. There was abnormal wear from the stem neck on the high side of the +4/10* liner. The liner appears to have been levered on at an inferior posterior position and broken directly across from site of stem impingement. The cup was cut out and new cup with different version was put in. This is the 2nd revision with the same issue. Surgeon remarked he could not trust the locking mechanism on this particular cup. Cup was put in (b)(6) 2014. Doi: (b)(6) 2018; dor: (b)(6) 2018; right hip.

 
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. 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 NameALTRX +4 10D 32IDX48OD
Type of DevicePINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46582-0988
5743725905
MDR Report Key7596419
Report Number1818910-2018-62061
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number122132148
Device LOT NumberH16308
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 Received10/30/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/05/2016
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: 06/13/2018 Patient Sequence Number: 1
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