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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 36ID X 56OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 36ID X 56OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS Back to Search Results
Catalog Number 121881756
Device Problem Material Fragmentation (1261)
Patient Problem Not Applicable (3189)
Event Date 11/14/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (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
Ceramic liner was placed into the cup as per surgical technique, upon impaction of this liner, it shattered into pieces.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the returned device was reviewed and failure mode confirmed.A review of complaint databases and manufacturing records did not identify any anomalies.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: null.Device history batch: null.Device history review: null.
 
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Brand Name
DELTA CER INSERT 36ID X 56OD
Type of Device
PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8155598
MDR Text Key130067472
Report Number1818910-2018-77883
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number121881756
Device Lot Number8372619
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2019
Initial Date Manufacturer Received 11/14/2018
Initial Date FDA Received12/12/2018
Supplement Dates Manufacturer Received02/07/2019
Supplement Dates FDA Received02/07/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Age54 YR
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