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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UKNOWN POLY LINER, SHOULDER BEARING; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. UKNOWN POLY LINER, SHOULDER BEARING; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problems Defective Component (2292); Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Type  Injury  
Manufacturer Narrative
Cmp-(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the patient was revised to address dislocation.Intra-operatively, the surgeon identified what was described as a defective poly liner.No further information has been made available at this time.
 
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Brand Name
UKNOWN POLY LINER, SHOULDER BEARING
Type of Device
PROSTHESIS, SHOULDER
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 Key7302274
MDR Text Key101127297
Report Number0001822565-2018-01227
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2018
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 Sequence Number1
Treatment
UNKNOWN PART/LOT, GLENOSPHERE
Patient Outcome(s) Hospitalization; Required Intervention;
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