MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122546

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Toxicity (2333); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 07/02/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain, elevated levels of cobalt and chromium, metallosis, osteolysis, fluid in the hip, pseudotumors, loss of mobility, cobalt toxicity, and bone loss.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the hemi head and modular sleeve were removed.The bhr cup and anthology 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.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.Cobalt and chromium levels pre-revision were 6.8mcg/l and 2.0mcg/l respectively.An unusual lesion within the marrow of the left iliac wing was reported.The revision operative report noted findings of significant corrosion found on the trunnion.The reported elevated cobalt and chromium levels and the intraoperative finding of significant corrosion are consistent with findings associated with metallosis; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported reactions cannot be confirmed, and 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: HEMI HEAD 46MM
• 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: 8593715
• MDR Text Key: 144518187
• Report Number: 3005975929-2019-00198
• 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
• Report Date: 11/15/2019

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 Catalogue Number: 74122546
• Device Lot Number: 08DW16740
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 05/01/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTHOLOGY STEM PART AND LOT # UNKNOWN; CUP PART AND LOT # UNKNOWN; INSERT PART AND LOT # UNKNOWN; MODULAR SLEEVE PART AND LOT # UNKNOWN; PART# 74222200, LOT# 08AW15336; ANTHOLOGY STEM PART AND LOT # UNKNOWN; CUP PART AND LOT # UNKNOWN; INSERT PART AND LOT # UNKNOWN; MODULAR SLEEVE PART AND LOT # UNKNOWN
• Patient Age: 65 YR