MAUDE Adverse Event Report: EXACTECH, INC. STEMLESS HUMERAL HEAD 47MM X 15MM X BETA; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 310-62-47

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 06/20/2022

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 300-60-01, 295874004 -stemless humeral comp laser cage, size 1 9999 - cage glenoid.

Event Description

It was reported that this 71 y/o female patient was converted a right stemless anatomic shoulder to a reverse total shoulder.Reason for this revision was not reported.Patient was last known to be in stable condition following the event.Product is not available for return.

Manufacturer Narrative

Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined; reason was not reported.Section h11: the following sections have corrected information: (b5) describe event or problem: it was reported that this 71 y/o obese female patient was converted a right stemless anatomic shoulder to a reverse total shoulder.Revision date is unknown; reason for this revision was not reported.There were no reported issues during the surgical procedure.The patient was last known to be in stable condition following the event.The product is not available for return.There has been no additional information provided after multiple attempts/requests.

Event Description

It was reported that this 71 y/o obese female patient was converted a right stemless anatomic shoulder to a reverse total shoulder.Revision date is unknown; reason for this revision was not reported.There were no reported issues during the surgical procedure.The patient was last known to be in stable condition following the event.The product is not available for return.There has been no additional information provided after multiple attempts/requests.

• Brand Name: STEMLESS HUMERAL HEAD 47MM X 15MM X BETA
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15503272
• MDR Text Key: 300777705
• Report Number: 1038671-2022-01199
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862556134
• UDI-Public: 10885862556134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 310-62-47
• Device Catalogue Number: 310-62-47
• Device Lot Number: 295874004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2022
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 86 KG