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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HIP CORE INSTRUMENT BASE CASE; HIP INSTRUMENTS : INSTRUMENT CASES
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DEPUY ORTHOPAEDICS INC US HIP CORE INSTRUMENT BASE CASE; HIP INSTRUMENTS : INSTRUMENT CASES Back to Search Results
Catalog Number 261124000
Device Problems Break (1069); Peeled/Delaminated (1454)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 07/08/2020
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
It was reported that there was no harm or delay.Attune total knee instrument trays were beginning to delaminate on the inside.The black pieces that hold instruments in place were starting to peel back.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument found the alleged complaint unconfirmed but found a different failure upon inspection of the instrument.Visual exam found the interior brackets broke off and were not returned.Base is heavily damaged due to scratching.Additionally, the inner tray and lid were not returned.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
 
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Brand Name
HIP CORE INSTRUMENT BASE CASE
Type of Device
HIP INSTRUMENTS : INSTRUMENT CASES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10489289
MDR Text Key205585643
Report Number1818910-2020-19421
Device Sequence Number1
Product Code FSM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number261124000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2020
Date Manufacturer Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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