MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM SO 12/14 SZ 1; PROSTHESIS,HIP,SEMI-CNSTRND,METAL/POLY,CEMENTED

Model Number	71312361
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered a periprosthetic fracture of the femur below a hip replacement.This was fixed with a stryker plate ,subsequently the stem has subsided due to non union of the fracture.It is unknown when this happened or the patient health.
Additional Manufacturer Narrative
H3,h6: it was reported that the patient suffered a periprosthetic fracture of the femur below a hip replacement.This was fixed with a stryker plate, subsequently the stem has subsided due to non union of the fracture.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation, therefore, no medical assessment can be performed at this time.Reportedly the root cause of the subsidence was the non-union; however, the root cause of the ppf along with other surgical details remains unknown.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: CPCS COCR PRIM SO 12/14 SZ 1
• Common Device Name: PROSTHESIS,HIP,SEMI-CNSTRND,METAL/POLY,CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10814176
• Report Number: 1020279-2020-06312
• Device Sequence Number: 13928715
• Product Code: JDI
• UDI-Device Identifier: 03596010462008
• UDI-Public: 03596010462008
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 06/23/2025
• Device Model Number: 71312361
• Device Catalogue Number: 71312361
• Device Lot Number: 15FM19691
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention