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

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

Patient Problems Pain (1994); Swelling (2091); Toxicity (2333); Injury (2348); Ambulation Difficulties (2544); Test Result (2695)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that the patient had right 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 experienced pain, loss of mobility and metallosis following right hip bhr implantation.As of today, additional information has been requested for this complaint but has not become available.All implanted devices were used in treatment.No revision surgery has been reported.The chartstiks for both devices involved in this complaint were provided in the received ppd, however due to scanning quality the bhr head batch number is obscured.Therefore it could not be included in the documentation review.A full complaint history review could not be performed for the head, so was performed using part number.A review of the complaint history for the cup was performed using batch number.Both were in search for similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup.Similar complaints have been identified for the head and this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the bhr cup reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product bhr cup ifu found adequate warnings and precautions in relation to the alleged failure modes.If additional information is made available surrounding the bhr head the documentation review will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.It was reported that the patient had right hip pain, fluid build up, elevated levels of cobalt and chromium, loss of mobility, and metallosis.No revision surgery has been confirmed yet.The operative report provided did not aid in the medical assessment investigation.Without supporting medical documentation, a thorough medical assessment of the reported event cannot be performed.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.In the event additional medical/clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.Without further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If additional information becomes 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 ACETABLR CUP
• 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: 8622132
• MDR Text Key: 145472344
• Report Number: 3005975929-2019-00215
• 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: 04/14/2020

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
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention