MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. TSS PRIMARY BODY 12STD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	B92002012STD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle/Tendon Damage (4532)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after tsa surgery had been performed on (b)(6) 2020, the patient cuff failed.This adverse event was solved by revision surgery on (b)(6) 2023, in which when from an anatomic system to a reverse system.The stem was well fixed but surgeon made decision to take out all hardware and revise with another system.Current health status of patient is unknown.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that, as of the date of this medical investigation, clinical documentation has not been received; therefore, it is unknown if the rotator cuff failure was a result of advancing disease, traumatic injury, or other factor(s).However, it is a known potential complication post shoulder arthroscopy and based on the limited information provided, it cannot be confirmed that the event is related to a mal performance of the component(s).Reportedly, the rotator cuff failure led to the revision and without patient specific medical documentation, no other potential contributing clinical factors could be concluded.The patient impact beyond the revision secondary to the reported cuff failure cannot be determined.No further medical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for titan¿ total shoulder system revealed that disabilities of other joints tend to adversely affect shoulder replacement implants, jeopardizing the efficacy of the implant.This has been identified as a warning.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient condition, abnormal motion over time and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.H6 (health effect - clinical code).

• Brand Name: TSS PRIMARY BODY 12STD
• 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: 18034431
• Report Number: 3002788818-2023-00091
• Device Sequence Number: 12808259
• Product Code: KWS
• UDI-Device Identifier: 10381780123118
• UDI-Public: 10381780123118
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K142413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2024

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: B92002012STD
• Device Lot Number: UNKNOWN
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 12/07/2023; 08/20/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/11/2023; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 44 YR
• Patient Sex: Female