MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN REDAPT ACET CUP; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number UNKN REDAPT ACET CUP

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

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 06/25/2020

Event Type  Injury  

Event Description

It was reported that on june 22nd a surgeon performed an revision procedure utilizing an or3o liner in a redapt modular acetabular shell.On june 23rd the patient dislocated and additional revision procedure to be performed.On june 25th the surgeon performed additional revision surgery altering the cup inclination to 45 degrees and utilized a new or3o dual mobility liner.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, this complaint from the united states reports two revisions just 3 days apart.The first revision secondary to unstable hip.The second revision was done secondary to dislocation the day after surgery.It has been communicated that further medical documents will not be forthcoming.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

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, two revisions were performed just 3 days apart on a patient with a history of ¿several revisions for repeated dislocations¿.Reportedly, the ¿(b)(6) revision¿ (captured under (b)(4)) was secondary to a ¿ very unstable hip despite several revision surgeries¿; however, no confirmation was received that this revision involved any s+n components.The june 25th liner revision¿ (case-2020-00010541) was reportedly performed along with ¿altering the cup inclination to 45 degrees¿ due a dislocation the day after revision (pod#1).It was communicated that the requested clinical documentation was not available.Based on the limited information provided, the root cause of the dislocation could not be concluded.The patient impact beyond the reported early dislocation and subsequent revision could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available in the future, this case may be re-opened/re-assessed.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, patient anatomy or abnormal loading of limb.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: UNKNOWN REDAPT ACET CUP
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10344620
• MDR Text Key: 201017649
• Report Number: 1020279-2020-03577
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKN REDAPT ACET CUP
• Device Catalogue Number: UNKN01100108
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention