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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. UNKNOWN HEAD PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. UNKNOWN HEAD PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 01/16/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Reported event is unable to be determined due to limited information provided by the customer. Dhr was unable to be reviewed as the lot number for the device is unknown. The root cause is unable to be determined. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02522. Device evaluated by manufacturer? insufficient information provided.
 
Event Description
It was reported that patient underwent a right hip revision approximately 13 years post implantation due to unknown reasons. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN HEAD
Type of DevicePROSTHESIS, HIP
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 Key10294732
MDR Text Key199453835
Report Number0002648920-2020-00347
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/27/2016
Device Model NumberN/A
Device Catalogue Number00801803202
Device Lot Number60475901
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/20/2020 Patient Sequence Number: 1
Treatment
UNKNOWN CUP; UNKNOWN LINER; UNKNOWN STEM
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