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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM INSERTER INSTRUMENT, HIP

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ZIMMER BIOMET, INC. UNKNOWN STEM INSERTER INSTRUMENT, HIP Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 10/30/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) (b)(6). Reported event was confirmed. Although the inserter was not returned, the acetabular shell was returned with a portion of the fractured inserter still seized inside of the shell's screw hole. The inserter screw fractured and a portion is bound within the threads of the shell. A hole is drilled through the screw fragment. Damage from the attempted removal can be observed on both the outside and inside of the shell. The inserter and fractured screw were not returned. Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown. Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It is reported that the cup inserter disassociated from the acetabular cup during attempted implantation. Upon receipt of the acetabular cup, it was discovered that the inserter had seized inside the cup and fractured off inside of the cup. The fractured portion was unable to be removed. The cup was removed and replaced with another implant. No additional patient consequences were reported. Attempts have been made and no further information is available.
 
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Brand NameUNKNOWN STEM INSERTER
Type of DeviceINSTRUMENT, 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 Key7434061
MDR Text Key105601427
Report Number0001822565-2018-02183
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
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?
Event Location No Information
Date Manufacturer Received04/16/2018
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: 04/16/2018 Patient Sequence Number: 1
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