MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/60; PROSTHESISHIPSEMICONSTRAINEDMETALMETALRESURFACING

Catalog Number 74122160

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

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 04/12/2019

Event Type  Injury  

Manufacturer Narrative

Smith & nephew, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, inc., or its employees, that the report constitutes an admission that the device, smith & nephew, inc., or its employees caused or contributed to the potential event described in this report.

Event Description

Us legal mdl it was reported that the patient underwent medically indicated revision of the bhr implants of the left hip on (b)(6) 2019 due to implant failure, adverse local tissue reaction, tissue damage, metallosis, elevated metal levels, abnormal fluid collection, pain, inflammation, and difficulty walking.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that left 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 / ifu 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.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (implant failure, adverse local tissue reaction, tissue damage, metallosis, elevated metal levels, abnormal fluid collection, pain, inflammation, and difficulty walking.) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.No further clinical assessment is warranted at this time.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, our investigation remains inconclusive and a definitive root cause cannot be determined.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 a medically indicated left hip revision surgery was performed.During the revision, both the acetabular cup and femoral head were explanted.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the acetabular cup and the femoral 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 acetabular cup or the femoral head.On account of the fact devices reportedly involved in this incident were not returned for evaluation, the relevant production records were reviewed.All released devices involved met manufacturing specifications upon release for distribution.Review of manufacturing records did not reveal any waivers, concessions, manufacturing, or material abnormalities that could have contributed to this issue.A non-conformance was identified for the casting paperwork for the femoral head.However, all supporting documents confirm that this was an acceptable product when released.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.No further actions are required at this time.The available medical documents were reviewed.Although it was reported the patient had mildly elevated cobalt and chromium levels, neither the levels nor the lab reports were provided for review.With the information provided, the root cause of the reported pain, mildly elevated cobalt, and chromium levels, synovitis, and wear debris type tissue cannot be confirmed and it cannot be concluded that the reported reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond the pain, revision, and expected transient post-operative convalescence period cannot be determined.Without the return of the actual products involved or additional information, our investigation remains inconclusive and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: ACETABULAR CUP HAP SIZE 52/60
• Type of Device: PROSTHESISHIPSEMICONSTRAINEDMETALMETALRESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11742844
• MDR Text Key: 247903741
• Report Number: 3005975929-2021-00200
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/01/2017
• Device Catalogue Number: 74122160
• Device Lot Number: 12AW35584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention