MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122150

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 12/08/2016

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on right hip due to elevated chromium and cobalt levels.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to elevated chromium and cobalt levels.During the revision the bhr head and bhr cup were removed.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.Per the primary right hip operative note there was ¿slight instability with excessive external rotation, adduction and flexion seen¿.Approximately 4.5 years later, the patient underwent a right revision/conversion.The revision/conversion operative report noted that the patient ¿never really felt better after the right hip resurfacing continued to report right-sided hip/groin pain which was worsened with activity, reported increasing popping/clicking in her right hip and showed elevated levels of cobalt and chromium in her blood.Intraoperatively it was found that the it band had an ¿extensive amount of scarring down to the vastus lateralis and gluteus muscles¿ and required the incision to be extended distally approximately 7-8 cm to facilitate exposure.Additionally, an ¿extensive amount of scarring¿ was ¿present around the resurfacing acetabular component¿ and required capsule dissection ¿along the posterior and superior remnants of the acetabular component¿.No supporting labs, units of measure, pathology results, or further clinically relevant supporting documentation were provided for inclusion in this medical investigation.The external rotation, adduction and flexion instability noted post reduction during the primary bhr and the extensive adhesions noted during the right revision/conversion tha are most likely the contributing factors to the reported lack of improvement post bhr, continued pain, increased popping, elevated metal ion levels, and subsequent right revision/conversion tha.However, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the source cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the reported symptoms, clinical findings, right hip revision/conversion to tha, and subsequent expected postoperative 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: ACETABULAR CUP HAP SIZE 44/50
• 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: 7613477
• MDR Text Key: 111459221
• Report Number: 3005975929-2018-00214
• 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
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 74122150
• Device Lot Number: 10JW30148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.; FEMORAL HEAD 44MM 74123144 LOT 08EW17046; BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR