MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120158

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Debris, Bone Shedding (1803); Failure of Implant (1924); Toxicity (2333); Osteolysis (2377)

Event Date 09/12/2016

Event Type  Injury  

Event Description

It was reported the left hip revision surgery was performed due to failed hip arthroplasty and metallosis.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup, hemi head and modular sleeve were removed.The echelon stem remained 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.The revision operative notes document; ¿chronic reaction with metallic debris.- there was a tremendous amount of debris - this was a very difficult case because the total reconstruction of the pelvis scar tissue was excised in all levels.There was a tremendous amount of black debris.There were defects in the medial, posterior, and anterior walls¿.The large amount of black discoloration and debris which may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It is unknown what caused the defects in the medial, posterior, and anterior pelvic walls.This might have been caused by residual cysts that caused the initial problem with her hip in 2008 or weakening from osteolysis due to a reaction to metal debris.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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: BHR ACETABULAR CUP 58MM
• 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: 7056697
• MDR Text Key: 92833112
• Report Number: 3005975929-2017-00406
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 74120158
• Device Lot Number: 077766
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2017
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN; HEMI HEAD, # 74122550, LOT # 10552; MODULAR SLEEVE, # 74222300, LOT # 07FW12484
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR