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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 51 MM O.D. PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. SHELL 51 MM O.D. PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical devices: part: 00500105028, lot: 64628874, liner 28 mm i. D. For use with 50/51/52 mm o. D. Shells; part: 802202802, lot: 64913231, zb 12/14 cocr hd 28mm x +0. Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00295, 0002648920-2021-00297.
 
Event Description
It was reported that a patient underwent a hip arthroplasty, subsequently, 7 months later the patient is being considered for a revision due to pain. Patient currently has a partial hip and will transition to total hip. Only cup, liner and head to be revised. Attempts have been made and no further information has been provided.
 
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Brand NameSHELL 51 MM O.D.
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 Key12533514
MDR Text Key273361314
Report Number0002648920-2021-00298
Device Sequence Number1
Product Code KWY
UDI-Device Identifier00889024115477
UDI-Public(01)00889024115477(17)290731(10)64485255
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K833991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00500105100
Device Lot Number64485255
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 Received09/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2019
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: 09/27/2021 Patient Sequence Number: 1
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