MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACC STD 265MM 11 CBL TRCH GRIP; CERCLAGE, FIXATION

Catalog Number	71340013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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 thr surgery had been performed on (b)(6) 2024, the patient experienced pain, discomfort, and a fracture along with one (1) acc std 265mm 11 cbl trch grip.According to the surgeon, bone union was attempted with the accord grip, but the fracture did not integrate.This adverse event was resolved by a revision surgery on (b)(6) 2025, in which the liner and insert were exchanged to or3o dual mobility liner 38/50 and or3o dual mobility xlpe insert 28/38 respectively, and the cup was exchanged to r3 multi hole acetabular shell 50mm.The head and stem were exchanged to competitor components.The current health status of the patient remains unknown.
Additional Manufacturer Narrative
H11: h2: additional information: concomitant devices added to the report.

• Brand Name: ACC STD 265MM 11 CBL TRCH GRIP
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22025096
• Report Number: 1020279-2025-00870
• Device Sequence Number: 9201846
• Product Code: JDQ
• UDI-Device Identifier: 03596010485823
• UDI-Public: 3596010485823
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K233949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 06/02/2025

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 Catalogue Number: 71340013
• Device Lot Number: 21FSM0450
• 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: 04/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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: Other; Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female