MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL ADAPTER TRAY, +15; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	322-10-15
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient underwent an initial shoulder replacement on the left side.Subsequently, the patient presented back to surgeon's office.X rays showed that the humeral try and torque defining screw disassociated from the humeral stem.Intra-operative findings confirmed this to be the case, as well as demonstrating that humeral liner was dissociated from humeral tray.The threaded portion of the torque defining screw, which was removed, was not broken.Patient was last known to be in stable condition following the event.Patient presented to surgeon's office.Xray confirmed that humeral tray and torque-defining screw were dissociated from humeral stem.Intra-operative findings confirmed this to be the case, as well as demonstrating that humeral liner was dissociated from humeral tray.It is my understanding that the threaded portion of the torque defining screw, which was removed, was not broken.Please describe when event occurred below.Sometime prior to surgery.It is unclear whether the patient experienced a fall leading to the issues.Is the reported event associated with revision of exactech implants? yes.What side was affected? left.Initial implant date (index surgery date) (b)(6) 2025.Was the patient revised to exactech devices? yes.Please describe below: dissociated items identified above were removed, and a 322-10-15 humeral tray was implanted and secured with a 320-20-00 torque defining screw kit.A 320-46-03 was also implanted.Is the reported event related to the breakage of a device? no.Did the reported event lead to a surgical delay/prolongation? no.It is unclear as to whether the patient may have fallen.Patient was last known to be in stable condition following the event.No images.X-ray and ebi are attached.Product not returning: hospital retains them.(b)(6) 320-46-13 equinoxe reverse 46mm humeral const liner +2.5.Udi#: (b)(4).510(k)#: k063569.Product code: kwt.(b)(6) 322-10-15 humeral adapter tray.Udi#: (b)(4).510(k)#: k223833.Product code: phx; kws; kwt.Concomitants: (b)(6) 320-08-46 - glenosphere exp 46mm +4mm offset.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-20-00 - eq reverse torque defining screw kit.
Additional Manufacturer Narrative
D10 concomitants: (b)(6) (b)(6) - glenosphere exp 46mm +4mm offset.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-20-00 - eq reverse torque defining screw kit.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive 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 obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, g3, h6, h11.**please disregard the device return date in d9.The device was not returned to the manufacturer.Mdr section codes updated/corrected: b, c, d.The revision was likely the result of disassembly of the torque defining screw and thus the humeral tray and liner assembly from the humeral stem and the disassembly of the humeral liner from the tray.The cause of the screw disassembly and sequence of events cannot be determined because the components were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: HUMERAL ADAPTER TRAY, +15
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22835662
• Report Number: 1038671-2025-02780
• Device Sequence Number: 15663414
• Product Code: KWS
• UDI-Device Identifier: 10885862593788
• UDI-Public: 10885862593788
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K223833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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 Catalogue Number: 322-10-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male