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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL REVERSE HUMERAL STEM SPACER 12MM; PROSTHESIS, SHOULDER

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ZIMMER BIOMET, INC. TRABECULAR METAL REVERSE HUMERAL STEM SPACER 12MM; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problem No Information (3190)
Event Date 03/29/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Additional report submitted for this event: mfr# 0001822565-2018-00148.Additional concomitant medical products: trabecular metal reverse poly liner 36mm plus 6mm offset, pn00434903606, ln62429272.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the revision procedure has not yet taken place.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported a patient has been indicated for a second left shoulder revision approximately 3.5 years post-implantation due to instability.No revision procedure has been reported to date.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Post revision x-ray review shows that the glenoid component appears to be horizontally positioned which may or may not contribute to the patient's instability given the high activity level of the patient.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.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.X-ray review states: left shoulder reverse arthroplasty without hardware failure or loosening.Small ossific density noted posterior to the joint space on the scapular y film.No fracture identified.No radiolucency.Cementing technique is poorly evaluated as no significant cement is identified along the humeral component.Patient's activity may contribute to the condition of instability.Glenoid component appears to be horizontally positioned which may or may not contribute to the patient's instability given their activity.Dhr was reviewed and no discrepancies were found.Review of complaint history determined that no further action(s) is/are required.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
It was reported a patient underwent a second left shoulder revision approximately 3.5 years post-implantation due to instability.Humeral stem spacer and poly liner were replaced with a custom device.
 
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Brand Name
TRABECULAR METAL REVERSE HUMERAL STEM SPACER 12MM
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 Key7218955
MDR Text Key98225233
Report Number0001822565-2018-00147
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK052906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/02/2018
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? Yes
Device Operator Physician
Device Expiration Date02/28/2023
Device Model NumberN/A
Device Catalogue Number00434903912
Device Lot Number62278467
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/03/2018
Initial Date FDA Received01/25/2018
Supplement Dates Manufacturer Received03/15/2018
03/30/2018
Supplement Dates FDA Received03/16/2018
04/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2013
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
Patient Outcome(s) Hospitalization; Required Intervention;
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