MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OR3O DUAL MOBILITY LINER 44/56; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71358205
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after tka, a revision surgery was performed due a dislocation and the inside of the or3o dual mobility liner 44/56 was found with wear.The patient outcome is unknown.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this case reports the patient underwent a tka revision due to dislocation.Per email correspondence, the requested surgical records and x-rays are not available.Therefore, the patient impact beyond the revision cannot be determined.Due to the lack of information provided, a clinical assessment cannot be rendered.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A visual inspection confirmed the or3o dual mobility liner 44/56 shows scratches.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Internal reference number: case-2021-00037230-1.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed scratches.The device shows significant signs of wear/usage.A lab analysis performed on the device revealed that scratches were observed on the articulating surface of the liner.Normal wear of the taper surfaces was observed from the liner locking into the shell.Additionally, deformation was observed on the taper surface.No manufacturing or material deviations were identified during this investigation.The cause of scratching on the liner¿s articulating surface and the deformation observed on the taper surface could not be determined.The clinical/medical investigation stated that, per email correspondence, the requested surgical records and x-rays are not available.Therefore, the patient impact beyond the revision cannot be determined.Due to the lack of information provided, a clinical assessment cannot be rendered.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.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 a similar event for the listed device over the previous 48 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 or3o¿ dual mobility system revealed 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.This has been identified as a warning.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 friction or joint tightness.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.Corrected data: h6 (medical device problem code).

• Brand Name: OR3O DUAL MOBILITY LINER 44/56
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 11305549
• Report Number: 1020279-2021-01089
• Device Sequence Number: 3371626
• Product Code: LPH
• UDI-Device Identifier: 00885556712269
• UDI-Public: 00885556712269
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71358205
• Device Catalogue Number: 71358205
• Device Lot Number: 20CM02435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/19/2021; 07/03/2024
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 02/24/2021; 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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