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

Catalog Number UNKNOWN

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

Patient Problems Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

Complaint reference: case-(b)(4).

Event Description

It was reported that a revision surgery was performed on the patient right hip on (b)(6) 2019.The revision surgery was performed due to an adverse local tissue reaction to metal debris and gray-stained tissue and joint fluid; pseudotumor; and elevated cobalt and chromium levels.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device batch numbers were provided for investigation, a manufacturing record, complaint history and device labelling / instructions for use review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.Without the implantation and pre-revision x-rays, it cannot be determined if the acetabular component was excessively anteverted; however, this cannot be ruled out as a contributory factor the reported clinical reactions; as the surgeon noted during the revision he ¿was careful to antevert it less.¿ without the supporting lab/pathology results, imaging and/or the analysis of the explanted components, the root cause of the reported pain, elevated metal ion levels, necrosis, discolored fluid and tissue cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period 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.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was performed.During the revision, the head and cup were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have 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 for the head and cup.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.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.The updated medical information was reviewed; however it relates to the left hip implantation surgery and does not change the previous assessment and conclusion.Without the implantation and pre-revision x-rays, it cannot be determined if the acetabular component was excessively anteverted; however, this cannot be ruled out as a contributory factor the reported clinical reactions; as the surgeon noted during the revision he ¿was careful to antevert it less.¿ without the supporting lab/pathology results, imaging and/or the analysis of the explanted components, the root cause of the reported pain, elevated metal ion levels, necrosis, discolored fluid and tissue cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period 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: UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10975249
• MDR Text Key: 220417943
• Report Number: 3005975929-2020-00487
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention