MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 26 MM +0; PROST,HIP,SEMCONSTR,MET/CER/POLY,CEMNTORNON-POR,UNCEMNT

Model Number	71342600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Joint Dislocation (2374)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to dislocation.No more information was initially provided.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from implantation / extraction.The clinical / medical investigation concluded that this complaint from japan reports that a revision was performed secondary to dislocations.The primary surgery was on (b)(6) 2020 and the revision just 2 months later on (b)(6) 2020.It has been communicated that no further documentation would be forthcoming.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.The dimensional evaluation could not confirm the stated failure mode.The device was found to be within specification.A review of complaint history did not reveal additional complaints for the listed batch.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 documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a fit/ sizing issue or procedural error.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 26 MM +0
• Common Device Name: PROST,HIP,SEMCONSTR,MET/CER/POLY,CEMNTORNON-POR,UNCEMNT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10745216
• Report Number: 1020279-2020-05870
• Device Sequence Number: 16908816
• Product Code: LZO
• UDI-Device Identifier: 03596010488893
• UDI-Public: 03596010488893
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

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: Lay User/Patient
• Device Model Number: 71342600
• Device Catalogue Number: 71342600
• Device Lot Number: 20BM21221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 05/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 75000176/SL-PLUS INTEGR MIA STEM WITH TI/HA 3/UNKN; 75000176/SL-PLUS INTEGR MIA STEM WITH TI/HA 3/UNKN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR