MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	71342800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Hip Fracture (2349); Unequal Limb Length (4534)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Bilateral patient.It was reported that, after a left bhr surgery was performed on (b)(6) 2007 due to progressing disabling of both hips, pain, and avascular necrosis, the patient suffered left hip impingement, for which left revision surgery was conducted on (b)(6) 2007.After that event, the patient experienced heterotopic ossification and elevated metal ions, for which a second revision surgery was performed on (b)(6) 2021.Subsequently, the patient experienced partial sciatic nerve palsy, leg length discrepancy and left hip greater trochanteric fracture.This adverse event was treated with a third revision surgery on (b)(6) 2021.The patient's current status is unknown.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the clinical root cause of the reported leg length discrepancy and left hip greater trochanteric fracture cannot be confirmed; however, the mixed manufacture construct cannot be ruled out as a contributing factor to the reported events.The s&n endoprostheses ifu (81007036 rev.G 2020-11) instructs ¿do not mix components from other manufacturers.¿ the partial sciatic nerve palsy is a known complication of hip replacement surgery and is related to the procedure and not the device.It cannot be concluded the nerve palsy is associated with a mal performance of the implant.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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.

• Brand Name: OXINIUM FEM HD 12/14 28MM +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 14466746
• Report Number: 1020279-2022-02489
• Device Sequence Number: 4596663
• Product Code: LZO
• UDI-Device Identifier: 03596010474148
• UDI-Public: 03596010474148
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71342800
• Device Catalogue Number: 71342800
• Device Lot Number: 20AM16215
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 06/30/2022
• Date Device Manufactured: 01/21/2020
• 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: Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Male