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 74122154

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 04/09/2019

Event Type  Injury  

Event Description

It was reported that, after a bhr tha surgery had been performed on the left hip, the patient experienced severe pain, limited mobility, and elevated cobalt and chromium levels.A revision surgery was performed on (b)(6) 2019 to address this event.Among the intra-operative findings and diagnoses were metallosis, and specifically trunnionosis and corrosion at the neck-stem junction, as a result of the premature failure of the device.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that a left hip revision surgery was performed.The devices involved were all used in treatment.As of today additional information have been requested for this complaint but have not become available.A review of the complaint history for the known devices hemi head and stem 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 stem and head.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.Review of the product's instructions for use 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 was reported the patient had elevated metal ion levels; however, neither the levels nor the lab reports were provided for review.Although the reported pain, elevated metal ions and intraoperative findings of grayish fluid, alval and trunnion corrosion may be consistent with findings associated with trunnionosis or metallosis; the root cause of the reported pain, elevated metal ions, grayish fluid, alval and trunnion corrosion cannot be confirmed and it cannot be concluded that the reported 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 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 left hip revision surgery was performed.During the revision, the bhr cup, hemi head, sleeve and stem 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, hemi head, short tapered stem 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 for the bhr cup, hemi head, or stem.Similar complaints were identified for the sleeve.However, as the device is no longer sold, no action is to be taken.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.None of the concessions involved 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 was reported the patient had elevated metal ion levels; however, neither the levels nor the lab reports were provided for review.Although the reported pain, elevated metal ions and intraoperative findings of grayish fluid, alval and trunnion corrosion may be consistent with findings associated with trunnionosis or metallosis; the root cause of the reported pain, elevated metal ions, grayish fluid, alval and trunnion corrosion cannot be confirmed and it cannot be concluded that the reported 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.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.No preventative or corrective action has been initiated as a result of this investigation.

• 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 ; UK
• MDR Report Key: 10853517
• MDR Text Key: 216659823
• Report Number: 3005975929-2020-00449
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2013
• Device Catalogue Number: 74122154
• Device Lot Number: 08FW17335
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR