MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122152
Health Effect - Clinical Codes	Pain (1994); Toxicity (2333); Test Result (2695)
Date of Event	02/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of the right hip was performed due to: pain, elevated cobalt and chromium, and metallosis.
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed due to pain, elevated cobalt and chromium levels, and metallosis.During the revision, the bhr cup and bhr head 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 head and cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the 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.The available medical documents were reviewed.Although it was reported that the cobalt and chromium levels were elevated, neither the exact levels nor the lab reports were provided.The intraoperative findings of pseudotumor, inflammatory tissue, and stained fluid/tissue are consistent with findings associated with metallosis; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported elevated cobalt and chromium levels, pain, metallosis, pseudotumor, inflammatory tissue, and stained fluid/tissue cannot be confirmed, and it cannot be concluded that the reported clinical 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, 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: ACETABULAR CUP HAP SIZE 44/52
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 8020606
• Report Number: 3005975929-2018-00404
• Device Sequence Number: 1368852
• Product Code: NXT
• UDI-Device Identifier: 03596010552280
• UDI-Public: 03596010552280
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: 74122152
• Device Catalogue Number: 74122152
• Device Lot Number: 08FW17304
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 02/06/2020; 09/07/2021
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 02/11/2020; 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74123144/FEMORAL HEAD 44MM/08DW16637.; 74123144/FEMORAL HEAD 44MM/08DW16637
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR