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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP INSERTER; HIPS, INSTRUMENTS

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ZIMMER BIOMET, INC. UNKNOWN CUP INSERTER; HIPS, INSTRUMENTS Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4).D10: unknown cup unknown 420049 3.5 straight hex ratchet shaft m hex unknown multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 -00205 0001825034-2024-00209 customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the insert fused into the handle of the g7 cup inserter and the screwdriver tip broke upon removal.No known impact or consequence to the patient.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6.No product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records and compatibility checks, and neither were provided.The reported issue cannot be confirmed.A definitive root cause cannot be determined.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 is available at the time of this report.
 
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Brand Name
UNKNOWN CUP INSERTER
Type of Device
HIPS, INSTRUMENTS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key18598015
MDR Text Key333983723
Report Number0001825034-2024-00204
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberUNKNOWN CUP INSERTER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/10/2024
Initial Date FDA Received01/29/2024
Supplement Dates Manufacturer Received05/13/2024
Supplement Dates FDA Received05/14/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE
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