MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Necrosis (1971); Toxicity (2333); Injury (2348); No Code Available (3191)

Event Date 03/18/2016

Event Type  Injury  

Event Description

It was reported that a revision surgery from the right hip was performed due to right hip failed hardware and metallosis cobalt and chrome with systemic cobaltism, right acetabular posterior column fracture, bone necrosis/cystic bone loss and pseudotumor due to metallosis.

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 and cup 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.Similar complaints have been identified for the head and this will continue to be monitored.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.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.No further actions are required at this time.The available medical documents were reviewed.The reported systemic cobaltism, metallosis and pseudotumor 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 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.It cannot be determined whether the fractured acetabular column was present or occurred during removal of the shell.It is also unknown to what degree the patient¿s body habitus was a contributing factor.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 re-opened.No preventative or corrective action has been initiated as a result of this investigation.

Event Description

It was reported that after a bhr construct was implanted on (b)(6) 2008, the plaintiff experienced right hip failed hardware, and metallosis cobalt and chrome with systemic cobaltism.A revision surgery was performed on (b)(6) 2016 to treat these adverse events.During the surgery a hip joint pseudotumor was encountered, the pseudotumor was mixed cystic/solid.Also, it was found that there was a large cavity cystic lesions on the acetabulum with grayish debris consistent with metallosis.During removal of the shell a nondisplaced crack in the posterior column of the acetabulum was noticed and repair with a plate.The plaintiff was discharged form the hospital on stable condition.

• Brand Name: ACETLR CUP HAP 52MM W/ IMPTR
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU32B-N ; UK HU32BN ; 0447940038
• MDR Report Key: 8370826
• MDR Text Key: 137166425
• Report Number: 3005975929-2019-00089
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: 74120152
• Device Lot Number: 077423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 74121146 RESURFACING FEMORAL HEAD 46MM 079083; UNKNOWN BHR DEVICE/ UNKNOWN LOT; UNKNOWN BHR DEVICE/ UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female