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 Material Disintegration (1177); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Toxicity (2333); Osteolysis (2377)

Event Date 02/29/2016

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to metallosis and extensive pelvic osteolysis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr head was removed.The cup remained implanted.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 bhr 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.Full device details have not been provided and therefore the production records could not be reviewed for the devices reportedly involved in this incident.However, all the released devices involved would have met manufacturing specifications at the time of production.Due to lack of device details provided, review of the specific product ifu could not be performed.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.Cloudy fluid was noted during the revision.It was sent for analysis, but no results were provided.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported metallosis and pelvic osteolysis cannot be confirmed and it cannot be concluded that the reported 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 reopened.No preventative or corrective action has been initiated as a result of this investigation.

• 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, CV313 HL; UK CV313HL
• MDR Report Key: 8010326
• MDR Text Key: 125192303
• Report Number: 3005975929-2018-00392
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 74120152
• Date Manufacturer Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121138/RESURFACING FEMORAL HEAD 38MM.; 74121138/RESURFACING FEMORAL HEAD 38MM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR