MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

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

Patient Problems Infiltration into Tissue (1931); Muscle Weakness (1967); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 01/19/2018

Event Type  Injury  

Event Description

Eu legal - bilateral patient.It was reported that, after bhr construct had been implanted on (b)(6) 2011 on the right hip, it was found high level of co cr in blood.A hypertrophic piriformis on the right hip was found.A revision surgery has not been performed yet.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was not performed on the bilateral patient.As of today, devices used in treatment, remain implanted in the patient and therefore cannot be evaluated.Additional information has been requested for this complaint but has not become available.A review of the complaint history was performed for the known devices.A review for bhr cup, modular head and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No similar complaints have been 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.Based on the limited information provided the clinical root cause of the reported events cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implants.The patient impact beyond the reported symptoms cannot be determined.Without further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Due to insufficient information provided we are unable to determine specific factors known to contribute to the alleged fault.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

H6:it was reported that right hip revision surgery was not performed on the bilateral patient.As of today, devices used in treatment, remain implanted in the patient and therefore cannot be evaluated.Additional information has been requested for this complaint but has not become available.A review of the complaint history was performed for the known devices.A review for bhr cup, modular head and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No similar complaints have been 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.The newly submitted lab results have been reviewed and do not change the conclusion drawn in the previous medical investigation report.Therefore, the previously completed medical investigation report remains valid.Based on the limited information provided the clinical root cause of the reported events cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implants.The patient impact beyond the reported symptoms cannot be determined.Without further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Due to insufficient information provided we are unable to determine specific factors known to contribute to the alleged fault.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative action is not indicated.

Manufacturer Narrative

B3 date of occurrence corrected.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was not performed on the bilateral patient.As of today, devices used in treatment, remain implanted in the patient and therefore cannot be evaluated.Additional information has been requested for this complaint but has not become available.A review of the complaint history was performed for the known devices.A review for bhr cup, modular head and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No similar complaints have been 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.Based on the limited information provided the clinical root cause of the reported events cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implants.The patient impact beyond the reported symptoms cannot be determined.Without further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Due to insufficient information provided we are unable to determine specific factors known to contribute to the alleged fault.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative action is not indicated.

• Brand Name: ACETLR CUP HAP 52MM W/ IMPTR
• 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: 11574588
• MDR Text Key: 242410042
• Report Number: 3005975929-2021-00161
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2014
• Device Catalogue Number: 74120152
• Device Lot Number: 100387
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention