MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM HD 10/12 26MM -5 EXT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Model Number	71341909
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to disassociation on (b)(6) 2020.It was revealed the ring of bipolar was left in the device.Problem was found out on (b)(6) 2020.The outcome of the patient is unknown.Investigation team indicated that a second device was returned (oxinium hd 10/12 26mm -5 ext) with the first one reported, this had not been reported previously to us.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that a revision surgery was performed due to disassociation on (b)(6) 2020.It was revealed the ring of bipolar was left in the device.Problem was found out on (b)(6) 2020.The outcome of the patient is unknown.
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 is heavily damaged around the outer rim from extraction.A dimensional evaluation of the returned device did not confirm the stated failure mode.A dimensional inspection found the device diameter to be within specification.The clinical/medical evaluation concluded that without the supporting medical imaging and/or the implantation and revision operative reports, the root cause of the reported disassociation cannot be confirmed; however, the heavily damaged lock ring from what appears to be impingement, cannot be ruled out as a contributing factor.It cannot be concluded that the reported event was associated with a mal performance of the implant.The patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.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 and potential harm was previously identified.Some potential probable causes for this event could include a traumatic injury or surgical technique.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 HD 10/12 26MM -5 EXT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10782320
• Report Number: 1020279-2020-06108
• Device Sequence Number: 11695510
• Product Code: LZO
• UDI-Device Identifier: 00885556112519
• UDI-Public: 00885556112519
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: Health Professional
• Device Model Number: 71341909
• Device Catalogue Number: 71341909
• Device Lot Number: 17GM07841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention