MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120156

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 11/14/2007

Event Type  Injury  

Event Description

Revision surgery was performed 2 days after implantation due to component malposition.Left hip.

Manufacturer Narrative

It was reported that a 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.Without definitive lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for the devices involved in search of complaints involving implant movement / migration throughout the lifetime of the product.Similar complaints have been identified for the cup and this failure will continue to be monitored.No similar complaints were found for the head, stem and sleeve.No lot numbers were provided; hence documentation review could not be completed.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 supporting documents, imaging, and/or the analysis of the explanted components, the root cause of the reported malposition of the devices cannot be determined but is likely due to the planning/technique of the procedure or the avascular necrosis noted during the implant.It cannot be concluded that the reported clinical reactions were associated with a malperformance 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.

Manufacturer Narrative

It was reported that a 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.A review of the complaint history for the bhr cup, bhr head, hemi head and modular sleeve 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 known 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 and no further actions are required at this time.The available medical documents were reviewed.It cannot be determined to what extent the osteophytes around the rim of the acetabulum had on the patients clinical status.The root cause of the malposition of the implant cannot be confirmed; however, it should be noted the post implantation x-ray report confirmed no dislocation.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: BHR ACETABULAR CUP 56MM
• 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: 8288933
• MDR Text Key: 134494007
• Report Number: 3005975929-2019-00037
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• 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,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71309114, LOT # UNKNOWN; HEMI HEAD, # 74122550, LOT # UNKNOWN; MODULAR SLEEVE, # 74222200, LOT # UNKNOWN; FEMORAL STEM, # 71309114, LOT # UNKNOWN; HEMI HEAD, # 74122550, LOT # UNKNOWN; MODULAR SLEEVE, # 74222200, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR