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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AEQUALIS PERFORM GLENOID; SHOULDER JOINT POLYMER PROSTHESIS
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AEQUALIS PERFORM GLENOID; SHOULDER JOINT POLYMER PROSTHESIS Back to Search Results
Model Number PEGGED SIZE S30
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032)
Date of Event 05/22/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event or Problem Description
"it was reported that a patient underwent a revision surgery due to rotator cuff insufficiency associated with pain and loss of range of motion 3 years after primary surgery.Patient id: (b)(6).".
 
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Brand Name
AEQUALIS PERFORM GLENOID
Common Device Name
SHOULDER JOINT POLYMER PROSTHESIS
MDR Report Key9509315
Report Number3000931034-2019-00187
Device Sequence Number388307
Product Code KWS
UDI-Device Identifier03700386937330
UDI-Public03700386937330
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K111902
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/26/2019
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 Lay User/Patient
Device Model NumberPEGGED SIZE S30
Device Catalogue NumberDWE301
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/26/2019
Initial Report FDA Received Date12/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age73 YR
Patient Weight93
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