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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK 12.5 MM TAPER LOCK STEM LATERAL OFFSET PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNK 12.5 MM TAPER LOCK STEM LATERAL OFFSET PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Patient Device Interaction Problem (4001)
Patient Problems Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)
Event Date 02/06/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00784, 0001825034 - 2022 - 00785.
 
Event Description
It was reported the patient underwent a left hip revision approximately 16 years post implantation due to pain, elevated metal ions, trendelenburg lurch, pseudotumor and abductor destruction. During the revision the trochanter was found bald with no abductors attached, no capsule, and appeared dead. Metal debris was inside of head and on the cup with mild trunnionosis. The head was exchanged without complications. The stem and cup remained implanted. Attempts have been made and no further information has been provided.
 
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Brand NameUNK 12.5 MM TAPER LOCK STEM LATERAL OFFSET
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 Key13976295
MDR Text Key288375973
Report Number0001825034-2022-00783
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 Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
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 Received04/26/2022
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: 04/01/2022 Patient Sequence Number: 1
Treatment
UNK 38 MM COBALT-CHROME HEAD; UNK 48 MM PRESS-FIT CUP
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