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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 44 MM O.D. HIP PROSTHESIS

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ZIMMER MANUFACTURING B.V. SHELL 44 MM O.D. HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Code Available (3191)
Event Date 02/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. (b)(4). Report source: (b)(6).
 
Event Description
It was reported that the ringloc on the cup was defective and prevented the liner from seating into the cup. The surgery was completed with another cup. Attempts have been made and no further information has been provided.
 
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Brand NameSHELL 44 MM O.D.
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8375608
MDR Text Key137314134
Report Number0002648920-2019-00146
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K833991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00500104400
Device Lot Number64193631
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/27/2019 Patient Sequence Number: 1
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