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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN LINER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problem No Code Available (3191)
Event Date 07/30/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 010000662 6449985 g7 pps ltd acet shell 50d, 00625006530 64339340 bone scr 6. 5x30 self-tap, unknown head, unknown stem. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown. 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 - 2019 - 03770, 0001825034 - 2019 - 03772.
 
Event Description
It was reported during hip surgery, the liner would not seat into cup. A second liner was opened and used. Upon reduction, the hip was determined to be unstable. After interop x-ray was performed, it was determined that the cup had moved during impaction of the second liner. The liner and femoral stem were removed, the cup was repositioned, screws were inserted, a new liner was inserted, the stem was re-inserted and the hip was reduced. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN LINER
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 Key8923863
MDR Text Key155321394
Report Number0001825034-2019-03771
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
N/A
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 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
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
Event Location No Information
Date Manufacturer Received01/06/2020
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: 08/22/2019 Patient Sequence Number: 1
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