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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Joint Dislocation (2374); Insufficient Information (4580)

Event Date 08/14/2020

Event Type  Injury  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 214475824
• Report Number: 1020279-2020-06108
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00885556112519
• UDI-Public: 00885556112519
• Combination Product (y/n): N
• PMA/PMN Number: K110101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention