MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122154

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Debris, Bone Shedding (1803); Failure of Implant (1924); Unspecified Infection (1930); Reaction (2414); Test Result (2695)

Event Date 01/04/2019

Event Type  Injury  

Event Description

It was reported a 2 stage right hip revision due to periprosthetic infection and adverse local tissue reaction related to corrosion.

Manufacturer Narrative

It was reported a 2 stage right hip revision due to periprosthetic infection and adverse local tissue reaction related to corrosion.As of today, device return and additional information has been requested for this complaint but has not become available.As no device batch numbers were provided for investigation, a manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The available medical documents were reviewed.This is a legal complaint from the united states reporting a right hip revision due to ¿periprosthetic infection and adverse local tissue reaction related to corrosion.¿ the date of the primary hip replacement was not provided.The revision was started on (b)(6) 2019 and was stated to be a 2 stage revision.The date for the second stage was not provided.The patient was not discharged until (b)(6) 2019.The second stage could have been done during that time but no supporting documents have been submitted to support this.Based on the available information the root cause for the ¿chronic infection¿ cannot be concluded.The infection was not identified in the material provided.The clinical information provided, of ¿murky fluid and the pseudotumour may be consistent with a reaction to metal debris or persistant infection.The source and the root cause cannot be determined with the available documentation.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.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the cup, hemi head, sleeve and stem 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.A review of the complaint history for the cup, hemi head, sleeve and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.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.No further actions are required at this time.The available medical documents were reviewed.The reported findings of elevated metal ion levels, altr and pseudotumor may be consistent with findings associated with metal debris.The patient¿s right hip infection is a possible root cause of the revision, and the metal reaction may be an incidental finding.However, it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient impact beyond the revision and expected post-operative healing/pain cannot be determined, and the patient¿s current condition is unknown.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.

Manufacturer Narrative

Patient age, test results and udi added.

• Brand Name: ACETABULAR CUP HAP SIZE 48/54
• 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: 9183957
• MDR Text Key: 162373087
• Report Number: 3005975929-2019-00359
• 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,Followup,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 74122154
• Device Lot Number: 07HW13405
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 09/27/2019; 09/27/2019; 09/27/2019
• Supplement Dates FDA Received: 12/24/2019; 02/11/2020; 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71357104 STEM, LOT 08LM11586A; 74122548 HEMI HEAD, LOT 08CW16124; 74222200 SLEEVE, LOT 08JW19031
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR