MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OR3O DUAL MOBILITY LINER 52/66-70; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71358211
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after a thr surgery performed on (b)(6) 2024, the patient had an inter prosthetic dislocation of the or3o liner and a depuy femoral head.A revision surgery was performed on (b)(6) 2024, in where the surgeon elected to replace the same s+n implants and a longer depuy head.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the provided x-ray was reviewed and confirms the dissociated head and liner.The adverse event was likely caused partially or wholly by the user of the product.The or3o oxinium surgical technique contraindications notes ¿do not use or3o oxinium dh liners with metal or ceramic femoral heads made from materials such as stainless steel, cocr, alumina, zirconia toughened alumina, oxinium, or oxinium dh.¿ the articul eze ceramic head is made of alumina composite material.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the or3o dual mobility liner a review of complaint history for the previous 12 months did not reveal similar events for the listed device.For the or3o dm xlpe insert 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 total hip systems revealed in the warnings and precautions section that improper neck selection, positioning, looseness of acetabular or femoral components, extraneous bone, penetration of the femoral prosthesis through the shaft of the femur, fracture of the acetabulum, intrapelvic protrusion of acetabular component, femoral impingement, periarticular calcification, and/or excessive reaming may increase the risk of dislocations and subluxation, which may lead to revision surgery.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.For the or3o dual mobility liner a historical review concluded that there are prior actions for the same device, but they cannot be linked to the complaint device.For the or3o dm xlpe insert 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 products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for additional corrective action is not indicated.Should the devices or 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.
Event or Problem Description
It was reported that, after a right hip revision surgery was performed on (b)(6) 2024 due to infection, the patient had an inter prosthetic dislocation of the or3o liner and a depuy femoral head.Another revision surgery was performed on (b)(6) 2024, in where the surgeon elected to replace the same s+n implants and a longer depuy head.The current health status of the patient is unknown.

• Brand Name: OR3O DUAL MOBILITY LINER 52/66-70
• 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: 20033237
• Report Number: 1020279-2024-01643
• Device Sequence Number: 6414276
• Product Code: LPH
• UDI-Device Identifier: 00885556712313
• UDI-Public: 885556712313
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K232667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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 Catalogue Number: 71358211
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OR3O DM XLPE INSERT 28/52: 71358224, A2007966
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown