MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM CONST HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-38-00
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported dislocation and revision are related to any design, manufacturing, or patient related issues.The cause of the revision is most likely is related to the patient¿s underlying condition; however, that could not be confirmed.Concomitant medical device(s): 320-10-00, equinoxe reverse tray adapter plate tray +0; 320-02-38, rs expanded glenosphere 38mm, +4mm offset; 320-15-07, sup/post aug plate, l rs glenoid baseplate.
Event or Problem Description
As reported, approximately 2 months postop the initial implant, this patient was twisting and felt a pop in the l shoulder which dislocated.The ltsa was revised during a same day surgery visit.The issue was noted as resolved.The device will not return due to clinical study policy.This information was reported by a clinical study database.All available information is reported.
Event or Problem Description
Approximately 4 month(s) and 12 day(s) post-operative of a revised left rtsa, it was reported via clinical study that the patient experienced a dislocation.The patient was doing band twist exercise (shoulder stationary) core type exercise.The patient underwent standard reverse revision and it was noted some wear at inferior liner and changed from constrained to standard.The outcome of this event is considered resolved and the clinical report indicates that this event is possibly related to the device(s) and definitely related to the procedure.
Additional Manufacturer Narrative
(d10): concomitant device(s): 320-02-42 - rs expanded glenosphere 42mm, +4mm offset: (b)(6) 320-15-05 - eq rev locking screw: (b)(6) 320-42-10 - equinoxe reverse 42mm humeral const liner +0: (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported may be the result of the dislocation as reported.Wear on the inferior liner was also noted during the revision surgery.However, the sequence of events and contributing factors cannot be determined from the provided information.The cause of the dislocation cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Dislocation is a known risk, as outlined in the ifu.Potential contributions of patient or user-related issues to the event cannot be determined from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: 145-DEG PE 42MM CONST HUM LINER +0
• Common Device Name: 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: geoff gannon ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 11371611
• Report Number: 1038671-2021-00071
• Device Sequence Number: 14137486
• Product Code: KWT
• UDI-Device Identifier: 10885862086716
• UDI-Public: 10885862086716
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2021
• Device Model Number: 320-38-00
• Device Catalogue Number: 320-42-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 09/03/2024; 07/07/2025
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 10/02/2024; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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 H10.; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: White