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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE HUMERAL TRAY STANDARD - TITANIUM; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE HUMERAL TRAY STANDARD - TITANIUM; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Joint Dislocation (2374); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Foreign Body In Patient (2687)
Event Date 12/20/2012
Event Type  Injury  
Manufacturer Narrative
(b)(4).Unique identifier (udi) #: n/a.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04874, 0001825034-2018-05004, 0001825034 - 2018 - 05005, 0001825034 - 2018 - 05006.
 
Event Description
It was reported the patient underwent a right reverse total shoulder arthroplasty revision approximately twenty (20) months post-implantation due to metallosis.During the surgery, the tray was noted to be fractured because of metal failure.Metallosis was noted in the shoulder joint and was also found behind the glenoid baseplate.There was additionally significant glenoid bone loss noted.The patient was converted to a hemi-arthroplasty.No additional patient consequences were reported.
 
Manufacturer Narrative
(b)(4).Reported event was confirmed by review of the operative notes received.As per the operative notes, severe metallosis was noted on the back side of the baseplate implant.The screwdriver head from the previous surgery had broken off in the locking screw and was locked into place.Trialed multiple heads and were unstable in the socket, no posterior glenoid for baseplate, surgery moved to resection arthroplasty.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined but the investigation results states that contributing conditions are multiple rotator cuff repairs and surgeon noted the patient had no subscapularis, supraspinatus, or infraspinatus.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.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.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 underwent a right reverse total shoulder arthroplasty revision procedure approximately twenty (20) months post-implantation due to pain, subluxation, metallosis, and limited range of motion.During the surgery, the tray was noted to be fractured because of metal failure.As per the x-ray, the cup device appears dislodged and abnormally oriented in relationship to the humeral stem component.The inferior glenoid shows sclerosis likely secondary to wear, the humeral base plate is not seated.Metallosis was noted in the shoulder joint and was also found behind the glenoid baseplate.There was additionally significant glenoid bone loss noted.The patient was converted to a hemi-arthroplasty.No additional patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Additional medical records were received and reported on may 10, 2019.Upon review of the information received, it was confirmed that the root cause remains undetermined as previously reported.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 Name
COMPREHENSIVE REVERSE HUMERAL TRAY STANDARD - TITANIUM
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7785129
MDR Text Key117189760
Report Number0001825034-2018-04864
Device Sequence Number1
Product Code PHX
Combination Product (y/n)N
PMA/PMN Number
PK080642
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2020
Device Model NumberN/A
Device Catalogue Number115340
Device Lot Number677200
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1103-2017
Patient Sequence Number1
Treatment
113634,COMPREHENSIVE HUMERAL STEM¿MINI,496150; 115310,VERSA-DIAL GLENOSPHERE STANDARD,619140; 115330,GLENOID BASEPLATE,583280; 115382,6.5 MM CENTRAL SCREW 3.5 HEX,781080; 118001,VERSA-DIAL TAPER ADAPTOR,618740; 180501,4.75 MM FIXED LOCKING SCREW 3.5 HEX,969000; 180502,4.75 MM FIXED LOCKING SCREW 3.5 HEX,044070; 180503,4.75 MM FIXED LOCKING SCREW 3.5 HEX,314030; 180509,4.75MMFIXED NON-LOCKING SCREW 3.5HEX,852650; 180509,4.75MMFIXED NON-LOCKING SCREW 3.5HEX,852650; XL-115363,ARCOMXL STANDARD HUMERAL BEARING,501580; 113634, COMPREHENSIVE HUMERAL STEM¿MINI, 496150; 115310, VERSA-DIAL GLENOSPHERE STANDARD, 619140; 115330, GLENOID BASEPLATE, 583280; 115382, 6.5 MM CENTRAL SCREW 3.5 HEX, 781080; 118001, VERSA-DIAL TAPER ADAPTOR, 618740; 180501, 4.75 MM FIXED LOCKING SCREW 3.5 HEX, 969000; 180502, 4.75 MM FIXED LOCKING SCREW 3.5 HEX, 044070; 180503, 4.75 MM FIXED LOCKING SCREW 3.5 HEX, 314030; 180509, 4.75MMFIXED NON-LOCKING SCREW 3.5HEX, 852650; 180509, 4.75MMFIXED NON-LOCKING SCREW 3.5HEX, 852650; XL-115363, ARCOMXL STANDARD HUMERAL BEARING, 501580
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
Patient Weight70
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