MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number	71357111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr surgery on (b)(6) 2016, the patient experienced a periprosthetic hip fracture.This adverse event was resolved by a revision surgery on (b)(6) 2024, where the anthology stem, femoral head, and liner of the r3 cup were removed.No further information is available at the moment.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H6: e2127 periprosthetic fracture.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 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.
Additional Manufacturer Narrative
B5, d10, h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, it was communicated that the requested clinical documentation was not available.The general health of the patient and further details of the event are unknown.A definitive clinical root cause of the reported event cannot be concluded based on the limited information provided.Patient impact beyond the reported revision cannot be determined.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for total hip systems revealed that congenital deformity, osteoporosis, bone defects, trauma, strenuous activity, patient non-compliance, etc.Can increase risk of femoral or pelvic fractures.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient bone quality and/or or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.
Event or Problem Description
It was reported that, after a thr surgery on (b)(6) 2016, the patient experienced a periprosthetic hip fracture.This adverse event was resolved by a revision surgery on (b)(6) 2024, where the anthology stem, femoral head, and liner of the r3 cup were removed.No further information is available at the moment.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 11
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20556026
• Report Number: 1020279-2024-02217
• Device Sequence Number: 16934726
• Product Code: MRA
• UDI-Device Identifier: 03596010559661
• UDI-Public: 3596010559661
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2025
• Device Catalogue Number: 71357111
• Device Lot Number: 15KM11275
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/27/2024
• Date Device Manufactured: 10/15/2015
• 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: OXINIUM FEM HD 12/14 36 MM +0.; PN: 71332760 / LOT: 16AM07288.; PN: 71343600 / LOT: 16AM07288.; R3 0 DEG XLPE ACET LNR 36MM X 60MM.
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male