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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNK CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Malposition of Device (2616)
Patient Problems Pain (1994); Metal Related Pathology (4530)
Event Date 10/27/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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: 0001825034 - 2021 - 03139, 0001825034 - 2021 - 03140.
 
Event Description
It was reported the patient underwent a hip revision for a head and liner exchange on a mclaughlin +5 cup. Explanted a metal 40mm head and there was significant trunionosis around the explanted head (inside and out) and around the neck trunnion of the stem. Patient previously had complained of pain. No additional information.
 
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Brand NameUNK CUP
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12852293
MDR Text Key281134400
Report Number0001825034-2021-03178
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/22/2021 Patient Sequence Number: 1
Treatment
UNK HEAD; UNK LINER; UNK NECK; UNK STEM
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