MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. REVERSE BODY SMALL AND BODY SCREW; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	BBS-0960-21SML
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case: (b)(6).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after tsa surgery had been performed on unknown date, the patient experienced that the screw broke, taper came apart and the proximal body dislocated.This adverse event was solved by revision surgery on (b)(6) 2024, in which the reverse body small and body screw and the tss cemented stem sz.06 were explanted.Current health status of patient is unknown.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).The reported devices were returned and evaluated.Updated sections: d9, h3, h6 and h11.H3, h6: results of investigation.The associated device was returned and evaluated.The visual inspection revealed that, the implant was still fixed to the liner and had a fractured portion of the body screw stuck in the blind hole, where the stem was mated.The remaining portion looked to be consistent with an implanted product.A lab analysis performed on the device revealed that the taper came apart, the body screw fractured, and the proximal body and stem separated.No defects were seen on the implants.It is not clear what initiated the fracture and separation.No material or manufacturing deviations were observed during this investigation.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 in the warnings section that the following conditions tend to adversely affect shoulder replacement implants, jeopardizing the efficacy of the implant: excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, disabilities of other joints.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.According with the implant and instrumentation manufacturing specification, all implants and instrumentation will be 100% visually inspected.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient anatomy, abnormal loading of limb, excessive forces and/or injury.Based on this investigation, the need for corrective action is not indicated.Should 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.

• Brand Name: REVERSE BODY SMALL AND BODY SCREW
• 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: 20678437
• Report Number: 3002788818-2024-00117
• Device Sequence Number: 8305037
• Product Code: KWS
• UDI-Device Identifier: 00885556863473
• UDI-Public: 885556863473
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 03/20/2026

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: BBS-0960-21SML
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 03/20/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TSS CEMENTED STEM SZ. 06: STEM-0950-025-06.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown