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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DELTA CER INSERT 36ID X 56OD; HIP ACETABULAR INSERT/LINER
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DEPUY IRELAND 9616671 DELTA CER INSERT 36ID X 56OD; HIP ACETABULAR INSERT/LINER Back to Search Results
Catalog Number 121881756
Device Problems Fracture (1260); Difficult To Position (1467)
Patient Problem No Information (3190)
Event Date 05/22/2017
Event Type  Injury  
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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 the surgeon was impacting the ceramic liner into a pinnacle duofix cup in the normal fashion; 4 taps to impact, on the fourth tap the liner twisted and shattered.As a result the surgeon had to extract the cup and liner and open a new implant.
 
Manufacturer Narrative
Depuy considers the investigation closed at this time.Should the 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 will be filed as appropriate.
 
Manufacturer Narrative
It was reported that the surgeon was impacting the ceramic liner into a pinnacle duofix cup in the normal fashion; 4 taps to impact, on the fourth tap the liner twisted and shattered.As a result the surgeon had to extract the cup and liner and open a new implant.The reported event has been evaluated and will be monitored.Depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
It was reported that the surgeon was impacting the ceramic liner into a pinnacle duofix cup in the normal fashion; 4 taps to impact, on the fourth tap the liner twisted and shattered.As a result the surgeon had to extract the cup and liner and open a new implant.The reported event has been evaluated and will be monitored.Depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
DELTA CER INSERT 36ID X 56OD
Type of Device
HIP ACETABULAR INSERT/LINER
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI  
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6654920
MDR Text Key78013717
Report Number1818910-2017-19829
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 05/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number121881756
Device Lot Number8378557
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/23/2017
Initial Date FDA Received06/20/2017
Supplement Dates Manufacturer ReceivedNot provided
09/01/2017
10/24/2017
Supplement Dates FDA Received06/28/2017
09/06/2017
11/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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