MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71331952

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hip Fracture (2349); Joint Dislocation (2374)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event 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 (b)(6) 2007 and (b)(6) 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, seventy two (72) of them were indicated due to a periprosthetic fracture associated to the femoral stem area.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.

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, 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, seventy two (72) of them were indicated due to a periprosthetic fracture associated to the femoral stem area.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 devices, used in treatment, were not received for investigation, a visual inspection could not be performed.The part and the batch number of the devices are 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 stated possible side effects resulting from hip 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).

Manufacturer Narrative

H10: this complaint was opened by smith+nephew to document a patient complication identified through a review of the national joint registry 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.Manufacturer report number corrected from 1020279-2022-00290.

Event Description

It was reported that, after a right thr index surgery performed on (b)(6) 2019 to address osteoarthritis symptoms, the patient sustained a dislocation/subluxation that made necessary a revision surgery on (b)(6) 2019.During this procedure, the acetabular cup, acetabular liner and the femoral head were explanted and replaced with a smith & nephew hip prosthesis construct.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: R3 3 HOLE HA CTD ACET SHELL 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, 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: 14682472
• MDR Text Key: 294904677
• Report Number: 9613369-2022-00290
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K201701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71331952
• Device Lot Number: 18KM06736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PN: 71337652 / LOT: 18GM19998; PN: 71343203 / LOT: 18FM14164; PN: 75100465 / LOT: B1821061
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 78 KG