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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 36IDX54OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 36IDX54OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 122136154
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 04/10/2019
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

It was reported that original implant date unknown. The doctor said the patient was in a deep squat and heard a pop, which was determined to be her liner disassociating from the cup. The doctor said the patients femur impinged on the elevated rim of the +4/10d liner and levered it loose. A new +4n liner and 36mm +12 head were used. Doi: unknown; dor: (b)(6) 2019, right hip.

 
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Brand NameALTRX +4 10D 36IDX54OD
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. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key8573697
MDR Text Key143836646
Report Number1818910-2019-92288
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062148
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number122136154
Device LOT Number755373
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 Received05/17/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/08/2016
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: 05/02/2019 Patient Sequence Number: 1
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