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	Joint Dislocation (2374); Subluxation (4525)
Date of Event	11/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after tha had been performed on (b)(6) 2018, the patient experienced dislocation/subluxation.Therefore, a revision surgery was performed on (b)(6) 2018 where r3 0 hole ha ctd acet shell 48mm ((b)(4)), r3 20 deg xlpe acet lnr 28mm x 48mm ((b)(4)), oxinium fem hd 12/14 28mm +0 ((b)(4)) and polarstem stem std ti/ha 01 non-cem ((b)(4)) were explanted.The current health status of the patient is unknown.This information was provided by the national joint registry for (b)(6) and the isle of man supplier feedback; therefore, further information is not available.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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.
Additional Manufacturer Narrative
Additional information: d4 (lot number, expiration date), h4.
Additional Manufacturer Narrative
Section h10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 24 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that dislocation that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components has been identified as warnings and precautions.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.Factors that could contribute to the reported event include traumatic injury, limited range of motion, patient anatomy, postoperative care or abnormal loading of limb.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.Internal complaint reference number: (b)(4).

• 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.; brooks rd. 1450; 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: 12240764
• Report Number: 1020279-2021-06069
• Device Sequence Number: 3635158
• Product Code: LZO
• UDI-Device Identifier: 03596010474148
• UDI-Public: 03596010474148
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/20/2022

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: 18FM17941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 10/25/2022; 10/25/2022
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/26/2021; 10/29/2022; 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2018
• 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
• Patient Sex: Female