MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM HO 12/14 SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71312372
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr was performed on (b)(6) 2017, it was noticed from the x-ray on 23-dec-2023 that the patient presented with peri-prosthetic fracture of the right proximal femur.A revision surgery was performed on (b)(6) 2023, in which a cocr 12/14 fem head 36mm +4 and a cpcs cocr prim ho 12/14 sz 2 were explanted.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint number: case (b)(4).
Additional Manufacturer Narrative
D4, d10, h6 have been updated.
Additional Manufacturer Narrative
Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided x-rays were reviewed and demonstrate stem subsidence and radiolucency at the stem cement interface, but the final image shows a proximal femoral shaft fracture that was distal to the stem tip.Based on the limited information provided the clinical root cause of the reported peri-prosthetic fracture cannot be confirmed.The fracture location is distal to the stem and though some of the images appear to demonstrate a subsidence over time it doesn¿t appear to relate to the femoral fracture.No patient activity was reported to indicate a cause of the fracture.Malperformance of the implant cannot be concluded.The patient impact is the fracture, revision, and postoperative convalescence period.No further clinical assessment is warranted at this time.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 device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed in warnings and precautions that congenital deformity, improper implant selection, improper broaching or reaming, osteoporosis, bone defects due to misdirected reaming, trauma, strenuous activity, improper implant alignment or placement, 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 product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient bone quality.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.D1: brand name, d2a: common device name, d2b: procode, d4: expiration date, g5:pma/510(k) # and h4: device manufacture date.

• Brand Name: CPCS COCR PRIM HO 12/14 SZ 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 18540384
• Report Number: 1020279-2024-00167
• Device Sequence Number: 12301086
• Product Code: JDI
• UDI-Device Identifier: 03596010462152
• UDI-Public: 03596010462152
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K823727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/17/2025
• Device Catalogue Number: 71312372
• Device Lot Number: 15KM14143
• 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: 12/23/2023
• Supplement Date Received by Manufacturer: 12/23/2023; 02/13/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/13/2024; 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71303604 / COCR 12/14 FEM HEAD 36MM +4.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown