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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN TRABECULAR METAL HUMERAL STEM; PROSTHESIS, SHOULDER

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ZIMMER, INC. UNKNOWN TRABECULAR METAL HUMERAL STEM; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Compatibility Problem (2960)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Synovitis (2094)
Event Date 02/28/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned [as it was kept by the hospital] 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: 0001822565-2017-02192 and 0001822565-2017-02194.
 
Event Description
It was reported that the patient underwent a left shoulder revision due to pain.During the revision, both metallosis and synovitis were noted as well as wear to the poly with fracturing.All components were removed and cement spacers were implanted.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of provided photographs.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.It is stated in revision op-notes that "the superior rotator cuff had been essentially torn and retracted" and "the glenoid component demonstrated complete loss of the central aspect of the poly-component with fracturing of the thinnest part of the poly.The poly was also delaminated from the trabecular metal." 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.
 
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Brand Name
UNKNOWN TRABECULAR METAL HUMERAL STEM
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6485413
MDR Text Key72535268
Report Number0001822565-2017-02194
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/05/2017
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 Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2017
Initial Date FDA Received04/12/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/05/2017
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
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age54 YR
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