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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BROACH INSTRUMENTATION, HIP

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ZIMMER BIOMET, INC. UNKNOWN BROACH INSTRUMENTATION, HIP Back to Search Results
Model Number N/A
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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.
 
Event Description
It was reported that during a hip procedure, the patient experienced a fracture after the incorrect sized broach was used. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Device history record review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to 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
No further event information available at the time of this report.
 
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Brand NameUNKNOWN BROACH
Type of DeviceINSTRUMENTATION, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7846837
MDR Text Key119249526
Report Number0001825034-2018-08718
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 04/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/05/2018 Patient Sequence Number: 1
Treatment
UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN STEM; UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN STEM
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