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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ZIMMER MULTIPOLAR BIPOLAR CUP LINER
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ZIMMER ZIMMER MULTIPOLAR BIPOLAR CUP LINER Back to Search Results
Catalog Number 00500104226
Device Problems Disassembly (1168); Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2014
Event Type  malfunction  
Event Description
It is reported that the locking ring was outside of the liner upon opening.The surgeon attempted to use it, however, the head was not moving smoothly so a new liner was opened and implanted.
 
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
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Brand Name
ZIMMER MULTIPOLAR BIPOLAR CUP LINER
Manufacturer (Section D)
ZIMMER
turpeaux industrial park
route 1, km. 123.4, bldg. 1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER
turpeaux industrial park
route #1, km. 123.4, bldg. 1
mercedita PR 00715
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key4307627
MDR Text Key22267254
Report Number2648920-2014-00335
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 10/30/2014
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 Expiration Date10/31/2021
Device Catalogue Number00500104226
Device Lot Number62510870
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/30/2014
Initial Date FDA Received11/25/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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