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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SHELL PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN SHELL PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Failure of Implant (1924); Itching Sensation (1943); Pain (1994); Rash (2033); Depression (2361)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown-unknown head-unknown. Implant date: (b)(6) 2006. Explant date: (b)(6) 2013. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 03258. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient underwent a right hip revision approximately 7 years post implantation due to pain, clicking, popping, implant popping out of place. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN SHELL
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 Key12924894
MDR Text Key281689487
Report Number0001825034-2021-03259
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 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
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 NumberNI

Patient Treatment Data
Date Received: 12/03/2021 Patient Sequence Number: 1
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