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

Catalog Number 74120148

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

Patient Problems Pain (1994); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 10/18/2017

Event Type  Injury  

Event Description

Left hip revision surgery was performed due to severe pain, limited mobility, elevated metal ion levels and metallosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup, modular sleeve and hemi head were removed.The synergy 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.The reported elevated cobalt and chromium levels, intraoperative findings of inflammation from adverse tissue reaction, black metal corrosion and histopathological findings are consistent with metallosis.The intraoperative findings of corrosion on the trunnion is a likely source of the metal debris.However, the root cause of the reported clinical findings cannot be confirmed.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The impact to the patient beyond the revision cannot be determined.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: BIRMINGHAM HIP RESURFACING
• 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: 8212792
• MDR Text Key: 131933378
• Report Number: 3005975929-2019-00001
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502551
• UDI-Public: 03596010502551
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120148
• Device Lot Number: 56942R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2018
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71309111, LOT # 06LM12280A; HEMI HEAD, # 74122542, LOT # 10046; MODULAR SLEEVE, # 74222200, LOT # 9941; FEMORAL STEM, # 71309111, LOT # 06LM12280A; HEMI HEAD, # 74122542, LOT # 10046; MODULAR SLEEVE, # 74222200, LOT # 9941
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR