MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120160

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Host-Tissue Reaction (1297); Toxicity (2333); Osteolysis (2377); Test Result (2695)

Event Date 12/19/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed to metallosis and adverse tissue reaction.

Manufacturer Narrative

Results of investigation (b)(6) i-0205203 it was reported that left hip revision surgery was performed due to metallosis and adverse tissue reaction.During the revision, the bhr head and bhr cup 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.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.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 head or the cup.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 available medical documents were reviewed.Although it was reported that the cobalt and chromium levels were mildly elevated, neither the levels nor the lab reports were provided.The reported swelling, elevated cobalt and chromium levels, debris, synovitis, erosion at the medial neck, and osteolysis are consistent with findings associated with metallosis; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reactions cannot be confirmed and it cannot be concluded that the reported clinical reactions 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.No further clinical assessment is warranted at this time.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: ACETABLR CUP
• 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: 7927852
• MDR Text Key: 122445459
• Report Number: 3005975929-2018-00348
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74120160
• Device Lot Number: 089784
• Date Manufacturer Received: 02/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BHR UNKNOWN DEVICE/ UNKNOWN LOT NUMBER.; RESURFACING FEMORAL HEAD 74121154, LOT 089378.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR