MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABLR CUPPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120160

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

Patient Problems Debris, Bone Shedding (1803); Pain (1994); Swelling (2091); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 07/03/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery of the left hip was performed due to: swelling, pain, numbness, sound in hip, left leg unable to support weight, sleeplessness, hip pain causing knee pain, difficulty walking requiring care, crutches or walker, joint deterioration, fluid around left hip, and other injuries and complications.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup and bhr head were removed.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 bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.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 a result of the reported event.The available medical documents were reviewed.The intraoperative findings of the reported inflammatory response, bone damage, and stained fluid are consistent with findings associated with metal debris; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported excessive wear of the femoral head and inflammatory response, bone damage, stained fluid, pain, and other 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 pain, revision, and expected transient post-op convalescence period 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: BHR ACETABLR CUPPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 8020614
• MDR Text Key: 125528904
• Report Number: 3005975929-2018-00402
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120160
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEAD 74121154, LOT 57860.; UNKNOWN BHR DEVICE/UNKNOWN LOT.; UNKNOWN BHR DEVICE/UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR