MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OR3O DM XLPE INSERT 28/46; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71358221
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a thr surgery was performed, the patient underwent a revision surgery on (b)(6) 2022 in order to replace the or3o dual mobility liner 46/60 with an r3 constrained liner.During surgery, it was noticed that the oxinium fem hd 12/14 28mm +0 and the or3o dm xlpe insert 28/46 had dissociated.It was unknown to surgeon if this resulted from the forces applied to the hip for dislocation during the procedure.The or3o dual mobility liner 46/60 was removed without surgical delay.Current health status of patient is unknown.
Additional Manufacturer Narrative
D4: expiration date, d7: if explanted, give date , d10: device available for evaluation? and h4: device manufacture date.Section h3, h6: the associated device was returned and evaluated.The visual inspection revealed the stated failure mode could not be confirmed.A dimensional evaluation performed by the quality engineering team on the device revealed that all except for the roughness and the inner diameter are within tolerance.As the evaluated parts, according the test frequency of the inspection instruction, are all within specification, it is suspected that the widening of the inner diameter arose from the input of the ball head into the insert.Additionally, the shape tolerance of the inner sphere is still within specification.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the head and poly dissociation.It is noted the event was addressed via revision surgery.The patient impact beyond the reported revision cannot be determined with the information provided.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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for or3o dual mobility system revealed in warnings and precautions that when the taper of the femoral stem is exposed, early impingement and excessive wear can occur.This may lead to failure of the retentive feature of the xlpe polyethylene insert and subsequent dissociation of the femoral head from within the xlpe insert.Modular components must be assembled securely to prevent disassociation.Prior to seating modular components, surgical debris, for example blood, bone, tissue, and bone cement must be cleaned from the surfaces.Debris may inhibit the component locking mechanism leading to implant failure and revision surgery.Also it warns to avoid repeated assembly and disassembly of the modular components which could compromise the critical locking action of the locking mechanism, resulting in component failure and 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 reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, surgical technique, size selected, postoperative care 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.H6: health effect - clinical code.

• Brand Name: OR3O DM XLPE INSERT 28/46
• 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: 15348859
• Report Number: 1020279-2022-03922
• Device Sequence Number: 5888429
• Product Code: LPH
• UDI-Device Identifier: 00885556712399
• UDI-Public: 00885556712399
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: 71358221
• Device Catalogue Number: 71358221
• Device Lot Number: A2002841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2020
• 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: Required Intervention
• Patient Sex: Unknown