MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122542

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

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Toxicity (2333); Osteolysis (2377)

Event Date 08/27/2014

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain, metallosis, synovitis, osteolysis, and elevated metal ion levels.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain, metallosis, synovitis, osteolysis, and elevated metal ion levels.During the revision the hemi head and modular sleeve were removed.The synergy stem and bhr cup remain implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the known 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.The available medical documents were reviewed.This case reports five year post implantation of a ltha this patient underwent a bhr revision to exchange the head to a mdm head due to pain, metallosis, synovitis, osteolysis, and elevated metal ion levels.The only clinical documents provided were the primary and revision operative reports.Intra-operative revision findings; there was a little synovial proliferation coming out soft tissues.About 10cc of turbulent greenish fluid was removed for culture and pathology.The posterior soft tissue envelope was elevated.The inside synovium was dissected out.There was significant synovitis approximately three and five mm thick throughout the joint.After the posterior synovium was cleaned, the surgeon performed a medial capsular release dislocated the head, and removed it.There was major trunnionosis, blackish staining of the trunnion and the sleeve.The trunnion was cleaned with sand paper per the revision.The trunnion and the femur were cleansed of all synovial tissue.There was a large osteolytic lesion on the posterior aspect of the femur that extended about eight cm distal on the femur.The stem itself was well fixed.Once the acetabulum was exposed an anterior and lateral synectomy was performed.There was some blackish staining right in the interface.After the surgeon finished cleaning he felt there was no significant osteolysis around the interface area.The clinical information provided is consistent with reactions from metal debris.However, the source cannot be confirmed.Additionally, neither the pathology reports, the explanted device, nor the metal ion levels provided for inclusion in this investigation.Therefore, it cannot be concluded that the reported clinical reactions are associated with a mal-performance of the implant.The impact to the patient beyond the revision cannot be concluded.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: HEMI HEAD 42MM
• 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: 6854764
• MDR Text Key: 85628874
• Report Number: 3005975929-2017-00270
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 74122542
• Device Lot Number: 08DW16721
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71309013/SYNPOR PLUS HASO STEMSZ13/09CM03427A; 74120148/ACETLR CUP HAP 48MM W/ IMPTR/81305; 74222300/MODULAR SLEEVE +4MM 12/14/07KW14454; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR