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

Model Number 74122542

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Tissue Damage (2104); Toxicity (2333); Injury (2348); Osteolysis (2377)

Event Date 05/30/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.Patient reported hip pain, elevated levels of cobalt and chromium, metallosis, adverse tissue reaction, osteolysis, pseudotumors, cobalt toxicity, severe bone loss, and other complications.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head and sleeve were removed.The bhr cup and 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 devices reportedly involved in this incident.The available medical documents were reviewed.The revision for the left hip was performed almost 11 years after implantation due to ¿metallosis¿.The revision operative report documents; ¿dark synovial fluid was present.We observed well fixed components, adverse soft tissue reaction and proximal femoral osteolysis.Also, the taper was mildly affected by corrosion.¿ the clinical information provided, of the elevated metal ion levels and the dark fluid as well as the soft tissue reaction, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.Correction mfr site: correct information.

• 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, CV313 HL; UK CV313HL
• MDR Report Key: 7935570
• MDR Text Key: 122787698
• Report Number: 3005975929-2018-00358
• 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: 10/13/2019

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: Health Professional
• Device Expiration Date: 04/30/2012
• Device Model Number: 74122542
• Device Lot Number: 10429
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71341023/ECH PRI FEM COMP HO SZ 13/05HM14080; 74120150/ACETLR CUP HAP 50MM W/ IMPTR/74714; 74222300/MODULAR SLEEVE +4MM 12/14/11476; BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR