MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OR3O DUAL MOBILITY LINER 44/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71358206
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate 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 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 the patient underwent a revision surgery of the right hip - fracture fixation system (unknown product) on (b)(6) 2021 due to nonunion of right intertrochanteric femur fracture, with screw cut-out of cephalomedullary screw.During the revision surgery, the trauma system was explanted and replaced with a tha acetabular redapt system and a femoral repadt system.As reported, the patient suffered from a deep wound infection on oct-2021, and underwent an additional surgery on that same month.During this procedure, the femoral head acetabular liner & insert were explanted.There is no further information at this time.The current state of health of the patient is unknown.

• Brand Name: OR3O DUAL MOBILITY LINER 44/58
• 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: 20230656
• Report Number: 1020279-2024-01849
• Device Sequence Number: 8912933
• Product Code: LPH
• UDI-Device Identifier: 00885556712276
• UDI-Public: 885556712276
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K232667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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?: No
• Device Catalogue Number: 71358206
• 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: 09/04/2024
• Initial Report FDA Received Date: 09/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71332535 / LOT: UNKNOWN; PN: 71336520 / LOT: UNKNOWN; PN: 71336530 / LOT: UNKNOWN; PN: 71342803 / LOT: UNKNOWN; PN: 71352358 / LOT: UNKNOWN; PN: 71354487 / LOT: UNKNOWN; PN: 71354502 / LOT: UNKNOWN; PN: 71358219 / LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 81 KG