MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. CARPAL POLY MEDIUM- STD; PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED

Catalog Number	262300
Medical Device Problem Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a wrist arthroplasty on (b)(6) 2022, the patient's (b)(6) (integra) universal 2 wrist replacement had excessive wear.This adverse event was solved by revision surgery on (b)(6) 2025 in which the system was explanted and revised to a swemac motec.The current patient's status is unknown.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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 submitting this report in accordance with applicable regulations.If additional investigative findings or 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 a wrist arthroplasty on (b)(6) 2022, the patient's s&n (integra) carpal poly medium- std had excessive wear.This adverse event was solved by revision surgery on (b)(6) 2025 in which the system was explanted and revised to a swemac motec.The current patient's status is unknown.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual evaluation of the returned devices finds integra wrist components, with the carpal poly medium- std.Edge surfaces exhibiting signs of mechanical stress and fraying.The body of the device is fractured through.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A laboratory analysis performed on the device revealed that that the fractured area is worn away and compressed.Given this finding, it cannot be ruled out that the fracture may have initiated during extraction in the procedure.No manufacturing deviations in the quality material were detected.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 universal2 total wrist implant system revealed in warnings that excessive physical activity and trauma affecting the replaced joint have been implicated in premature failure by loosening, fracture, or wear of the implants.Additionally.Revealed in adverse effects that it is important to remove all debris following cement application since studies have shown that bone cement particles may cause increased wear rates and reduce the service life of the implant materials.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 to the material specification, the quality and manufacture of 7.5 mrad cross-linked ultra-high-molecular-weight polyethylene (uhmwpe) bar stock shall be controlled.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 friction, joint tightness, 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.We consider this investigation closed.

• Brand Name: CARPAL POLY MEDIUM- STD
• Common Device Name: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
• 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: 21491558
• Report Number: 3002788818-2025-00019
• Device Sequence Number: 3942061
• Product Code: JWJ
• UDI-Device Identifier: 00885556865019
• UDI-Public: 885556865019
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

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: 262300
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: Not provided; 07/29/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 05/21/2025; 08/01/2025
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 261301/LOT: UNKNOWN; PN: 263300LF/LOT: GT0460
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown