MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER,

Model Number	71342808
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after a thr surgery performed on (b)(6) 2021, a revision surgery had to be conducted on (b)(6) 2021 due to pain.An oxinium fem hd 12/14 28mm +8 was explanted.Surgeon states that the devices were not defective or loose.Current patient status remains unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, the patient had a revision due to pain.Per the case details, the surgeon stated the devices were not defective or loose.It is noted via e-mail correspondence within the attachments that no further clinical/medical information is available.Therefore, based on insufficient information, no further medical assessment can be performed at this time.The patient impact beyond that which has already been reported cannot be determined.Should any additional relevant clinical information be provided, this complaint would be re-assessed.A review of complaint history 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.The instructions for use documents revealed this failure mode was previously identified.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.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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 +8
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12753876
• Report Number: 1020279-2021-07846
• Device Sequence Number: 4775318
• Product Code: LZO
• UDI-Device Identifier: 03596010474179
• UDI-Public: 03596010474179
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 71342808
• Device Catalogue Number: 71342808
• Device Lot Number: UNKNOWN
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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