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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN PINNACLE CUP TRIAL SIZE 32 54+4 10 HIP INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN PINNACLE CUP TRIAL SIZE 32 54+4 10 HIP INSTRUMENT/TRIAL Back to Search Results
Catalog Number 221832152
Device Problems Break (1069); Component Missing (2306)
Patient Problem No Information (3190)
Event Date 06/08/2017
Event Type  malfunction  
Manufacturer Narrative
Examination of the returned instruments confirmed the complaint. 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
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. Complete product detail has not been received at this time. If further information is received a follow-up medwatch will be filed as appropriate. 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 pinnacle cup trial size 32 54 +4 and size 32 52 +4 10° came out of washing machine without silver threaded center.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
 
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Brand NameUNKNOWN PINNACLE CUP TRIAL SIZE 32 54+4 10
Type of DeviceHIP INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6693739
MDR Text Key105341927
Report Number1818910-2017-20794
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number221832152
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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