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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM POSITIVE STOP PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT

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DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM POSITIVE STOP PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT Back to Search Results
Model Number 1246-03-000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 01/29/2020
Event Type  malfunction  
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
The customer reported that the hole eliminator has been turned through the pinnacle 100 acet cup 50mm and landed in the small pelvin. No patient harm nor significant delay reported.
 
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Brand NameAPEX HOLE ELIM POSITIVE STOP
Type of DevicePINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JJM (SUZHOU) LTD. 3006356043
no.299 changyang st
suzhou industrial park
suzhou jiangsu 21512 -6
CH 21512-6
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9717069
MDR Text Key189874114
Report Number1818910-2020-05017
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K042992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1246-03-000
Device Catalogue Number124603000
Device Lot NumberD19100426
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 Received03/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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