MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 8X80MM DISTAL STEM MODULAR CEMENTED

Catalog Number	308-01-08
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This (b)(6) patient with an average build had an initial surgery a couple years ago by oncology to remove a tumor in this right shoulder.The distal stem became loose and was revised on (b)(6) 2019 with a new stem, collar, and proximal body.The tray height was also built up.All available information has been received.Devices have not returned.Upon review of all the information, the cause of the loosening is likely related to the patient¿s previous cancer which likely resulted in poor bone quality.Concomitant device(s): distal fixation ring ha 19.5 (cat# 308-05-19).Med prox body +0 (cat# 308-10-00).
Event or Problem Description
This (b)(6) patient with an average build had an initial surgery "a couple years ago".The reported indication for the initial implantation was due to removal of a tumor in this right shoulder (oncology).On (b)(6) 2019, it was noted that the distal stem had become loose.The stem, collar and proximal body were revised.The tray height was also built up.All available information has been received.Devices are not available for returned.Upon review of all the information, the cause of the loosening is likely related to the patient¿s previous cancer which likely resulted in poor bone quality (pre-existing condition).

• Brand Name: EQUINOXE
• Common Device Name: 8X80MM DISTAL STEM MODULAR CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9503593
• Report Number: 1038671-2019-00613
• Device Sequence Number: 2981440
• Product Code: HSD
• UDI-Device Identifier: 10885862267894
• UDI-Public: 10885862267894
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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: Health Professional
• Device Catalogue Number: 308-01-08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR