MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OR3O DM XLPE INSERT 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71358222
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr surgery had been performed on an unknown date, the patient fell and one (1) or3o dm xlpe insert 28/48 disassociated from one (1) oxinium fem hd 12/14 28mm +0.This adverse event was solved by a revision surgery on (b)(6) 2025, in which the devices were replaced with new 48/62 or30 liner, 28/48 or30 insert, and 28mm +8 oxinium head.Current health status of patient remains unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4): this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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 submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The associated devices were returned and evaluated.A visual inspection of the returned device finds the insert significantly worn and discolored with deep grooves in the edge.The oxinium femoral head is also heavily damaged, the damage may have been caused by extraction activities.Devices' batch numbers were not provided; thus, an evaluation of the manufacturing records could not be performed.For the insert, a review of complaint history for the previous 12 months did not reveal similar events for the listed device.For the femoral head, a review of complaint history of the previous 12 months revealed similar events for the listed part number, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event are injury, 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.Factors that could contribute to the reported event include injury, patient condition, postoperative care, size selected or abnormal loading of limb.

• Brand Name: OR3O DM XLPE INSERT 28/48
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23511679
• Report Number: 1020279-2025-01869
• Device Sequence Number: 15879252
• Product Code: LPH
• UDI-Device Identifier: 00885556712405
• UDI-Public: 885556712405
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

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 Catalogue Number: 71358222
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 04/10/2026; 06/30/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 04/16/2026; 07/01/2026
• 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: OXINIUM FEM HD 12/14 28MM +0, PART#:71342800; OXINIUM FEM HD 12/14 28MM +0, PART#:71342800.; PN: 71342800 / LOT: 23MM06152; PN: 71358208 / LOT: 22AM09576
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown