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 Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Inflammation (1932); Pain (1994); Toxicity (2333); Injury (2348)

Event Date 02/27/2018

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to elevated metal ion levels, metallosis, fluid collection on mri, loss of hip function, pain, instability, inflammation and squeaking.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.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 head.Similar complaints were identified for the cup 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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 and no further actions are required at this time.The medical records were reviewed.Although the metal ion levels were reported to be elevated, neither the values nor the lab reports were provided.The root cause for the scar tissue cannot be concluded but some patients can be genetically predisposed, it is a known complication of joint surgeries and is related to the procedure and not the device.The reported pain may be associated with the intraoperative findings of fluid distention; however without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain 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.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

*us legal* it was reported that after a left bhr construct was implanted on (b)(6) 2011, plaintiff experienced elevated metal ion levels, metallosis, fluid collection on mri, loss of hip function, pain, instability, inflammation, and squeaking.A revision surgery was performed on (b)(6) 2018 to treat these adverse events.During surgery a distention of the capsule due to fluid was found.6 weeks after revision surgery patient was reported to be stable and under normal recovering process.

• 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 ; 7000 west william cannon drive; austin, TX ; 0447940038
• MDR Report Key: 8835046
• MDR Text Key: 152453130
• Report Number: 3005975929-2019-00276
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 74120152
• Device Lot Number: 10HW29690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 74121146 RESURFACING F HEAD 46MM 10JW29983; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female