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

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 12/30/2014

Event Type  Injury  

Event Description

Us legal mdl.It was reported that the patient underwent medically indicated revision of the bhr implants of the right hip on (b)(6) 2014 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 the patient underwent left hip revision.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, 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 and no further actions are required at this time.The available medical documents were reviewed.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, 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.

Event Description

*us legal mdl* it was reported that the patient underwent medically indicated revision of the bhr implants of the right hip on (b)(6) 2014 due to implant failure, adverse local tissue reaction, tissue damage, metallosis, elevated metal levels, abnormal fluid collection, pain, inflammation, and difficulty walking.Intraoperatively, a moderately extensive pseudotumor was involving the trochanteric bursa and moderate osteolysis.The patient outcome is unknown.

Manufacturer Narrative

It was reported that a revision surgery was performed on the patients right hip.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 head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.A non-conformance was identified for the castings inspection procedure paperwork for the bhr 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 and no further actions are required at this time.The available medical information was reviewed.Although it was reported the patient had elevated metal ion levels, neither the levels nor the lab reports were provided for review.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion and 40-45° inclination angle.However, the operative report indicated the acetabular component was implanted at 20 to 25° of anteversion.It is unknown if the increased anteversion of the acetabular component and/or the posterior impingement led to accelerated wear, and the reported pain, elevated ions, and intraoperative findings of pseudotumor, osteolysis and synovitis.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period 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.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)
• 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: 11735979
• MDR Text Key: 247672211
• Report Number: 3005975929-2021-00198
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2021

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 Operator: Health Professional
• Device Expiration Date: 07/30/2013
• Device Catalogue Number: 74122160
• Device Lot Number: 08GW17927
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR