MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 ACETABULAR CUP; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 74120158

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Debris, Bone Shedding (1803); Joint Dislocation (2374); Test Result (2695)

Event Date 03/05/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to displaced acetabular component at the right hip.R3 acetabular cup was removed.

Event Description

It was reported that revision surgery was performed due to displaced acetabular component at the right hip with fracture of periacetabular bone.R3 acetabular cup was removed.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the head / cup / stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the stem and cup, however, these complaints are from the same patient / device.No similar complaints were identified for the head.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.The oxinium head and anthology stem involved met manufacturing specifications at the time of production.Nonconformance was identified for the machining paperwork for the acetabular cup.However, all supporting documents confirm that this was an acceptable product when released.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.It was noted that use of a competitor¿s (stryker) dual mobility liner was implanted with the bhr cup at the time of revision.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information, ¿do not mix components from other manufacturers.¿ the available medical documents were reviewed.The revision for elevated cocr levels and acetabular loosening are consistent with findings associated with metal debris.However, without the supporting lab/pathology results, radiographs, and/or the analysis of the explanted components, the root cause of the reported symptoms noted in the legal claim cannot be confirmed, and it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient impact beyond the revision and post-operative healing cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: R3 ACETABULAR CUP
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN
• MDR Report Key: 8399294
• MDR Text Key: 138101683
• Report Number: 1020279-2019-00954
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 74120158
• Device Lot Number: 086094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2008
• 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: 28MM FEMORAL HEAD.
• Patient Sex: Male