MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71335756

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Pain (1994); Impaired Healing (2378)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, after a thr surgery, one syn por fem comp sz 13, one r3 3 hole acet shell 56mm, one oxinium fem hd 12/14 36 mm -3, and one r3 20 deg xlpe acet lnr 36mm x 56mm were associated with a post-operative reaction (pain, infection and unhealed incision).This happened after use in patient.The issue was resolved with a revision surgery, in which the surgeon removed all the implants.Current health status of the patient is unknown.

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, this case reports the patient complaint of pain, infection and unhealed incision after a thr surgery.A ¿revision¿ surgery was performed to explant all devices.The patient¿s current health status is unknown.No relevant supporting clinical information has been provided to assist with a clinical investigation.The root cause of the revision/component explants was most likely the reported infection; however, the root cause of the infection, pain and unhealed incision could not be definitively concluded.The patient impact beyond the reported events could not be determined.No further medical assessment is warranted.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 are not limited to traumatic injury, joint tightness, patient reaction, contamination, patient reaction, and post-operative healing issue.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: R3 20 DEG XLPE ACET LNR 36MM X 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12511046
• MDR Text Key: 272658590
• Report Number: 1020279-2021-07042
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010598356
• UDI-Public: 03596010598356
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71335756
• Device Catalogue Number: 71335756
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 65 YR