MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV COCR 10/12 TAPER FEM HD 26MM +5 EXT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	11911
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tha primary surgery was performed on (b)(6) 2018, a revision surgery was performed on (b)(6) 2024 due to pain and dislocation with pelvic fracture from a fall.The tandem liner (tndm bp shl/xlpe lnr 47od 26id) and the femoral head (univ cocr 10/12 taper fem hd 26mm +5 ext) were exchanged to ox head, r3 xlpe liner and r3 cup.The stem (syn sel ii por so 10/12 sz 13) was remained.The current health status of the patient is unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, it was reported the patient had a total hip arthroplasty on (b)(6) 2018, and a revision (b)(6) 2024 due to pain and dislocation with pelvic fracture from a fall.Therefore, there were no clinical factors found that would have attributed to this event.The liner and the femoral head were exchanged to oxinium head, r3 xlpe liner and r3 cup.The synergy stem remained in situ.The patient impact was the revision.Device batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed devices.A review of the instructions for use documents for total hip systems and endoprostheses systems revealed dislocation risks are associated with improper neck length and cup selection, incorrect stem positioning, muscle looseness, and component misalignment.It's important to assess acetabular cartilage viability and check for irregularities that could lead to subluxation or dislocation.Correct neck length and stem positioning are crucial, as muscle laxity or component misalignment can also cause these issues.Dislocations and subluxations are noted as adverse effects.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 include traumatic injury.Based on this investigation, the need for 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.

• Brand Name: UNIV COCR 10/12 TAPER FEM HD 26MM +5 EXT
• 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: 19863023
• Report Number: 1020279-2024-01474
• Device Sequence Number: 8111703
• Product Code: LPH
• UDI-Device Identifier: 00885556008904
• UDI-Public: 00885556008904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 11911
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 09/09/2024
• 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