MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 SHELL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKN01100901

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

Patient Problem Joint Laxity (4526)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

(b)(6) legal bilateral patient.It was reported that, after a first revision surgery performed to explant the originally implanted r3-tha construct on the plaintiff¿s left hip (covered under (b)(4)), the plaintiff experienced joint instability which led to a second revision surgery been performed on (b)(6) 2018.During this surgery, the surgeon noted that the acetabular cup was neutral or at least not sufficiently anteverted; therefore, the r3 three hole coated hemispherical shell 60mm was explanted, along with the unknown xlpe insert 56 mm and the unknown oxinium femoral head 36mm +8.No malfunction was reported to occur related to the xlpe insert and oxinium femoral head 36mm, as they were presumably exchanged to fit the bigger size cup implanted during this surgery (62mm).Surgery was completed without any complications.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the information provided, the acetabular component was not sufficiently anteverted.Therefore, the reported joint instability is related to a procedural variance and is not associated with a malperformance of the implant.The patient impact beyond the subsequent revision cannot be determined.No further clinical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to fit/sizing issue, lifetime of device, surgical technique used or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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: UNKN R3 SHELL
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12537341
• MDR Text Key: 273535199
• Report Number: 1020279-2021-07190
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100901
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 70 YR