MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO STEM 300MM SZ14 SO; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 71354738

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Dislocation (2374)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a revision thr had been performed on (b)(6) 2021, the patient experienced a dislocation and it was determined that the stem was loose.This adverse event was solved by revision surgery on (b)(6) 2021.Current health status of patient is unknown.

Manufacturer Narrative

A2: age added.A3: gender added.(b)(4).

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, per complaint details, the patient experienced dislocation ¿after a revision thr¿ and underwent revision approximately 4 weeks later due to determination of ¿stem loose¿.A post-revision x-ray report dated (b)(6) 2021 was provided; however, it does not provide insight into the reported event.No further clinically relevant documentation has been provided as of the date of this medical investigation.Although the root cause of the revision was reportedly dislocation and stem loosening, this could not be confirmed nor concluded based on the documentation provided.The patient impact beyond the reported dislocation, stem loosening and revision could not be determined.Reportedly, the current health status of patient is healthy.Further patient impact could not be concluded.No further medical assessment could be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.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: REDAPT SLVLS MONO STEM 300MM SZ14 SO
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12471544
• MDR Text Key: 271440850
• Report Number: 1020279-2021-06840
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00885556579596
• UDI-Public: 00885556579596
• Combination Product (y/n): N
• PMA/PMN Number: K151902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71354738
• Device Catalogue Number: 71354738
• Device Lot Number: 15FTM0011N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR