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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE SHOULDER SYSTEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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TORNIER INC AEQUALIS FLEX REVIVE SHOULDER SYSTEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Model Number ARS741702
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/27/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
Event or Problem Description
It was reported that the patient underwent a surgical procedure on the shoulder.Allegedly the patient underwent a revision surgery due to loosening/lysis.
 
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Brand Name
AEQUALIS FLEX REVIVE SHOULDER SYSTEM
Common Device Name
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
MDR Report Key10988162
Report Number3004983210-2020-00047
Device Sequence Number3562276
Product Code KWS
UDI-Device Identifier00846832069293
UDI-Public00846832069293
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K181420
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/16/2020
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? Yes
Operator of Device Health Professional
Device Model NumberARS741702
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/16/2020
Initial Report FDA Received Date12/10/2020
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 Required Intervention;
Patient Weight68
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