MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122154

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

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Arthralgia (2355); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that the patient had left hip pain, fluid buildup, elevated levels of cobalt and chromium, loss of mobility, and metallosis.No revision surgery has been confirmed yet.

Manufacturer Narrative

It was reported that a patient had left hip pain, fluid buildup, elevated levels of cobalt and chromium, loss of mobility, and metallosis.No revision surgery has been confirmed yet.The implanted devices were all used in treatment.As of today, additional information has been requested for this complaint but have not become available.A review of the complaint history for the bhr cup and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.It was reported that the patient had left hip pain, fluid buildup, elevated levels of cobalt and chromium, loss of mobility, and metallosis.The implantation operative report indicates the patient had a left bhr done 03/01/2011 for osteoarthritis.The operative report did not aid in the medical assessment investigation.Without supporting medical documentation, a thorough medical assessment of the reported event cannot be performed.In the event additional medical/clinical records are received, the clinical task will be reopened and a thorough assessment will be rendered at that time.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 re-opened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: ACETABULAR CUP HAP SIZE 48/54
• 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: 8622140
• MDR Text Key: 145472268
• Report Number: 3005975929-2019-00216
• 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: 04/21/2020

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: 08/31/2015
• Device Catalogue Number: 74122154
• Device Lot Number: 10HW29485
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74123148 FEMORAL HEAD 48MM 10HW29554; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention