MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	71343600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a thr surgery performed on (b)(6) 2022, the patient suffered a dislocation.A revision surgery was performed on (b)(6) 2022, in where a r3 3 hole ha ctd acet shell 52mm, a r3 20 deg xlpe acet lnr 36mm x 52mm and a oxinium fem hd 12/14 36 mm +0 were explanted.The current health status of the patient is well.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the dislocation and subsequent revision.The patient impact beyond the reported revision cannot be determined with the limited information provided.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 batches 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 a review of ifu for total hip systems revealed that dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.A review of the risk management file 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 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.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury, limited range of motion, patient anatomy, postoperative care or abnormal loading of limb.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.

• Brand Name: OXINIUM FEM HD 12/14 36 MM +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: 16134839
• Report Number: 1020279-2023-00066
• Device Sequence Number: 6610177
• Product Code: MEH
• UDI-Device Identifier: 03596010477279
• UDI-Public: 03596010477279
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 71343600
• Device Catalogue Number: 71343600
• Device Lot Number: 22FM13655
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/03/2023
• Date Device Manufactured: 06/20/2022
• 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: R3 20 DEG XLPE ACET LNR 36MM X 52MM, LOT#:22HM1935; R3 3 HOLE HA CTD ACET SHELL 52MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown