MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM M/+4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71343604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a primary surgery (thr), during this surgery a liner, one oxinium head, 3 screws, and one stem were implanted.6 weeks post-operative, the patient presented a dislocation of the thr, feeling a slipping sensation in certain positions.After that, a mua/revision of right thr was performed.The surgeon did a revised through the daa approach and the head and liner were removed and a new liner and new head were implanted.Additionally, it was inserted a hood of a liner positioned laterally for extra coverage.The wound was irrigated and closed in layers as per the technique.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that the patient presented a dislocation of the thr, feeling a slipping sensation in certain positions.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 the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.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.A medical analysis noted that upon presentation for the mua/revision tha the hip couldn¿t dislocate until bringing in x-ray and leveraging against contralateral thigh, as the ¿thigh habitus was impinging and acting as a fulcrum to lever hip out¿.The revision was concluded with the hood of liner positioned laterally for extra coverage per product complaint form.Responses to clinical documentation/information requests were not provided; therefore, the root cause of the dislocation and subsequent revision could not be definitively concluded.However, the reported body habitus and ¿certain positions¿ could not be ruled out as potential contributing factors.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: OXINIUM FEM HD 12/14 36 MM M/+4
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10604062
• Report Number: 1020279-2020-04936
• Device Sequence Number: 2940830
• Product Code: HRY
• UDI-Device Identifier: 03596010477286
• UDI-Public: 03596010477286
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 02/18/2021

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 Model Number: 71343604
• Device Catalogue Number: 71343604
• Device Lot Number: 20BM16861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 02/18/2021
• 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
• Patient Weight: 170