MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71342800
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	07/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, from data obtained from the national joint registry (uk) for twenty thousand sixty three (20063) patients who underwent primary implantation of thr - smith and nephew components comprising a cementless polarstem and a combination of several femoral heads, liners and cups between 23-jul-2007 and 19-sep-2021, a total of two hundred thirty one (231) hips were revised due to several reasons, which were accounted for a total of two hundred sixty nine (269) preoperative diagnosis.From these, six (6) were indicated due to postoperative fracture of the femoral stem prosthesis.The specific details in regards of the identity of the explanted components and the ones implanted in exchange are not known.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
In the national joint registry uk (summary.Report.Hp_stem_polarstem cementless_onlabel) [1], it was reported that for twenty thousand sixty three (20063) patients who underwent primary implantation of thr - smith and nephew components comprising a cementless polarstem and a combination of several femoral heads, liners and cups between (b)(6) 2007 and (b)(6) 2021, six (6) were indicated due to postoperative fracture of the femoral stem prosthesis.The specific details in regards of the identity of the explanted components and the ones implanted in exchange are not known.No further information is available.The complaint device, used in treatment, was not received for investigation, a visual inspection could not be performed.The part and the batch number of the device is not known.Therefore, the batch record review could not be performed.A complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.The device labeling was reviewed, the ifu for the complaint device (lit.No.12.23, ed.03/21) stated failure of the implant among possible side effects resulting from knee arthroplasty.Due to insufficient information, it is not possible to perform a review of past corrective actions.For the medical investigation, no relevant supporting clinical information could be provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Should any additional clinical information be provided, this complaint will be re-evaluated.Based on our investigations the failure mode cannot be confirmed and the root cause of the problem stays undetermined due to insufficient information.A relationship between the reported event and the device cannot be confirmed.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.[1]: national joint registry, summary.Report.Hp_stem_polarstem.Cementless_onlabel.29/11/2021.15:02, ©2021 nec software solutions (uk) limited.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Results of investigation: this complaint was opened by smith+nephew to document a patient complication identified through a review of the (b)(6) from united kingdom 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.This report was submitted under manufacturer number 9613369, the correct manufacturer number is 1020279.
Event or Problem Description
It was reported that, after a right thr index surgery performed on (b)(6) 2018 to address osteoarthritis symptoms, the patient experienced a dislocation/subluxation that made necessary a revision surgery on (b)(6) 2019.During this procedure, the femoral head and the acetabular liner were explanted and replaced with similar devices.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent a primary thr surgery with a hip prosthesis construct that included a polarstem and an r3 shell and that required a revision surgery due to specific reasons.As such, no further information will be available.

• Brand Name: OXINIUM FEM HD 12/14 28MM +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 14719521
• Report Number: 9613369-2022-00308
• Device Sequence Number: 17508725
• Product Code: LZO
• UDI-Device Identifier: 03596010474148
• UDI-Public: 03596010474148
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2022
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 71342800
• Device Catalogue Number: 71342800
• Device Lot Number: 18EM12834
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 07/13/2022; 10/25/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 08/03/2022; 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2018
• 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: POLARSTEM STEM STD TI/HA 1 NON-CEM, LOT#:B1812314; R3 20 DEG XLPE ACET LNR 28MM X 54MM, LOT#:17FM2145; R3 3 HOLE HA CTD ACET SHELL 54MM, LOT#:18FM21557; UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female