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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEMENT RESTRICTOR WITH NOZZLE; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. CEMENT RESTRICTOR WITH NOZZLE; PROSTHESIS, SHOULDER Back to Search Results
Model Number 00-8400-094-00
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr's were filed in association with this reporting: 0001822565 - 2019 - 05408, 0001822565 - 2019 - 05409, 0001822565 - 2019 - 05410, 0001822565 - 2019 - 05411, 0001822565 - 2019 - 05412.:concomitant medical products 00840001507 ulnar component plasma sprayed size 5 lot 63127158, primary di# 00889024271241, 00840004410 humeral component plasma sprayed size 4 lot 63319031, primary di# 00889024271340, 00840009000 humeral screw kit lot 63969924 primary di# 00889024271449, 00840009400 articulation kit size 4 lot 64129150, primary di# 00889024271456.Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
 
Event or Problem Description
It was reported the patient is being considered for a revision to address infection and related pain less than a year post implantation.No further information is available as the patient has not yet been revised.
 
Event or Problem Description
No further event information available at the time of this report.
 
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.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.
 
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Brand Name
CEMENT RESTRICTOR WITH NOZZLE
Common Device Name
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9537500
Report Number0001822565-2019-05412
Device Sequence Number14022203
Product Code JDC
UDI-Device Identifier00889024271456
UDI-Public(01)00889024271456
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K040389
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date01/31/2021
Device Model Number00-8400-094-00
Device Catalogue Number32810503800
Device Lot Number63252559
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/18/2019
Supplement Date Received by Manufacturer03/04/2020
Initial Report FDA Received Date01/02/2020
Supplement Report FDA Received Date03/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		N/A
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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