MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM -3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERA/POLY, CEMEN OR NON-POROUS, UNCEM

Model Number	71343203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case-(b)(4).
Event or Problem Description
It was reported that, after a thr was performed on (b)(6) 2019 the patient presented recurrent dislocation.Therefore, a revision surgery was performed on 23-feb-2022 in order to treat this adverse event, in which the oxinium fem hd 12/14 32mm -3 was removed and replaced with a new oxinium femoral head.The primary synergy stem was left in-situ.The surgeon does not blame the implants.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device was found to be scratched and damaged along its surface, likely from the explantation process.A review of complaint history revealed similar events for the listed device over the previous 12 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.The clinical/medical evaluation concluded that it was reported that a revision surgery was performed due to recurrent dislocation.The photos were reviewed, and visual inspection of the returned device noted, damage along base, likely from the event of the dislocation or the removal of the device from the patient; however, without supporting medical documentation, a thorough medical assessment of the clinical root cause of the dislocations cannot be performed.In the event additional medical/clinical records are received, the clinical task may be reopened, and a thorough assessment will be rendered at that time.It is noted, the surgeon does not blame the implants.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported event could not be corroborated.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.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 32MM -3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERA/POLY, CEMEN OR NON-POROUS, UNCEM
• 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: 14836693
• Report Number: 1020279-2022-03135
• Device Sequence Number: 17341804
• Product Code: LZO
• UDI-Device Identifier: 03596010474216
• UDI-Public: 03596010474216
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 71343203
• Device Catalogue Number: 71343203
• Device Lot Number: 19EM01472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 68 KG