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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)
Event Date 10/15/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: zimmer stem cat#00771101010 lot#64172709. Zimmer shell cat#00500104400 lot#64316784. Zimmer head cat#00877502802 lot#2992432. Foreign report source: (b)(6). The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00828. 0002648920 - 2020 - 00160.
 
Event Description
It was reported the patient developed fever and wound exudation approximately 1 week after initial tha and was given anti-infection treatment, wound debridement and dressing change. Approximately 3 weeks later, patient underwent debridement surgery. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameLINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS
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 Key9819563
MDR Text Key191137100
Report Number0002648920-2020-00159
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K833991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00500104428
Device Lot Number64302970
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 Received03/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2019
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: 03/11/2020 Patient Sequence Number: 1
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