MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. FIN-LOCK GLENOID. M; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	GLN-0926-030-02A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a total shoulder replacement surgery with titan, the patient experienced a rotator cuff failure.For that reason, a conversion to a reverse shoulder replacement was performed on (b)(6) 2023.Patient current health status is unknown.
Event or Problem Description
It was reported that, after a total shoulder replacement surgery with titan performed on (b)(6) 2021, the patient experienced a rotator cuff failure.Further diagnostics on (b)(6) 2022 showed ¿full-thickness tearing of the subscapularis tendon with retraction to the glenohumeral joint and contrast communicating from glenohumeral joint into the subacromial subdeltoid bursa.Marked fatty atrophy of the superior and moderate fatty atrophy of the mid subscapularis muscle.The humeral head component abuts the coracoid.¿ for that reason, a conversion to a reverse shoulder replacement was performed on (b)(6) 2023.The patient is currently doing very well with his new reverse system.
Additional Manufacturer Narrative
B5, d1, d4, d6a, d10, g4 h3, h4, h6: the product has not been returned to the aus site for evaluation and photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed.- complaint history review: the complaint history review identified no similar reported events for this device.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.- risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.- dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.- capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.- device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.- product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.- clinical medical evaluation: supporting clinical documentation has not been provided; therefore, no clinical factors could be concluded to have contributed to the reported event.Patient impact beyond the reported revision/conversion along with an anticipated rehab phase cannot be determined.No further medical assessment can be rendered at this time.- visual inspection: a visual inspection could not be performed as the device was not returned.The complaint alleges that revision surgery was required.As the device has not been returned for evaluation, a determination of whether the device contributed to the reported event could not be made.As the device has not been returned, a definitive root cause could not be determined.The titan total shoulder system (tss) consists of several implantable components: the stem and body, the humeral head, and the glenoid.The complaint does not indicate which if any of these components caused or contributed to the reported event.The complaint indicates that the patient experienced a rotator cuff failure following the implantation of the tss, requiring revision surgery.According to risk documentation for tss, potential causes for the reported event include incorrect surgical technique, incorrect patient selection, or improper handling post-implantation.Based on this investigation, the need for corrective action is not indicated as no non-conformances nor manufacturing deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.

• Brand Name: FIN-LOCK GLENOID. M
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16372328
• Report Number: 3002788818-2023-00015
• Device Sequence Number: 20520273
• Product Code: KWS
• UDI-Device Identifier: 00885556860328
• UDI-Public: 00885556860328
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 04/11/2023

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: 04/01/2024
• Device Model Number: GLN-0926-030-02A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 191506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 04/11/2023
• Date Device Manufactured: 05/04/2019
• 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: PN: BOD-0923-020-10STD / LOT: 161984; PN: BSW-0920-021-01 / LOT: 183209; PN: MHH-0923-010-4818E / LOT: 162694; PN: STEM-0920-025-11 / LOT: 192490
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown