MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122154

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Tissue Damage (2104); Toxicity (2333); Injury (2348); Reaction (2414)

Event Date 11/01/2018

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to metallosis, elevated blood levels of chromium and cobalt; hyperplasia, chronic hip joint inflammation, cloudy fluid accumulation around hip joint, adverse local tissue reaction, sinus tract formation, metal debris into the pelvis, soft tissue damage, loosening of the implant and failed left hip arthroplasty.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision the acetabular cup & femoral head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup and head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup and the head.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.The bhr cup involved met manufacturing specifications at the time of production.Non-conformance was identified for the castings inspection procedure paperwork for the bhr head.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.The medical documents were reviewed.It should be noted during implantation the acetabulum was reamed to 54mm and a 54 mm cup was placed.Pain, cloudy whitish fluid and adverse local tissue reaction may be associated with metal debris.However, without the supporting lab results, imaging and the analysis of the explanted components, the source of the reactions cannot be confirmed, and it cannot be concluded that the reported 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.Based on the available information, a root cause of improper loading has been suggested due to the incorrect reaming of the acetabulum before implanting the acetabular component.The surgical technique states that ¿sequential reaming with hemispherical acetabular reamers is then performed and in normal consistency bone, reaming proceeds to 2mm less than the definitive acetabular component to be inserted¿.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: ACETABULAR CUP HAP SIZE 48/54
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8575820
• MDR Text Key: 143931016
• Report Number: 3005975929-2019-00190
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 74122154
• Device Lot Number: 11HW33928
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74123148 FEMORAL HEAD 48MM L# 11JW34074; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR