MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OR3O DM XLPE INSERT 28/44; PROSTHESISHIPSMICONSTRAINDMTALPOLYMRPOROUSUNCMNTD

Catalog Number	71358219
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr surgery had been performed on (b)(6) 2021, the patient went to er with a hip dislocation.This adverse event was solved by a revision surgery performed on (b)(6) 2021, in which it was confirmed that the head had disassociated from the insert.A smith and nephew back up device was used.Current health status of patient is unknown.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device shows signs of extensive use.The clinical/medical evaluation concluded that per complaint details, a revision surgery was performed 3 days post implantation due to a hip dislocation.It was communicated that during the surgery it was ¿confirmed that the head ((b)(4)) had disassociated from the insert¿ ((b)(4)) and that a s+n back up device was used.The current health status of the patient remains unknown.The requested medical documentation has not been provided as of the date of this medical assessment.Reportedly, the noted disassociation was the root cause of the dislocation and revision; however, the root cause of the disassociation could not be concluded.The assessed patient impact is the reported dislocation/ disassociation and subsequent revision.Further patient impact could not be concluded.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available and/or a product evaluation conclusion results in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.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.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.
Additional Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.The visual inspection revealed signs of extensive use.A lab analysis performed on the device revealed that scratches were observed on the outer articulating surface of liner.Scratches were observed on the articulating surface of the femoral head.Additionally, scratches were observed near and slightly inward of the bore taper of the femoral head.No manufacturing or material deviations were identified during this investigation.The cause of the scratching on the insert and the femoral head could not be determined.The clinical/medical investigation stated that the requested medical documentation has not been provided as of the date of this medical assessment.Reportedly, the noted disassociation was the root cause of the dislocation and revision; however, the root cause of the disassociation could not be concluded.The assessed patient impact is the reported dislocation/disassociation and subsequent revision.Further patient impact could not be concluded.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available and/or a product evaluation conclusion results in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 42 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.A review of the instructions for use documents for dual mobility system revealed in the warnings section that proper positioning of the components is important to minimize impingement which could lead to early failure, premature wear, device related noise, and/or dislocation, all of which may lead to revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient condition 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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: OR3O DM XLPE INSERT 28/44
• Common Device Name: PROSTHESISHIPSMICONSTRAINDMTALPOLYMRPOROUSUNCMNTD
• 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: 12318978
• Report Number: 1020279-2021-06350
• Device Sequence Number: 11796511
• Product Code: LPH
• UDI-Device Identifier: 00885556712382
• UDI-Public: 00885556712382
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 71358219
• Device Lot Number: A2018758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 10/20/2021; 08/12/2024
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 10/20/2021; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown