MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 48MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120148
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Respiratory Insufficiency (4462); Metal Related Pathology (4530)
Date of Event	06/06/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, after bhr implant surgery performed in (b)(6) 2003, due to severe pain, a revision surgery was performed in (b)(6) 2011, there is a diagnosis for metallosis, and there is still a lot of pain, and respiratory issues reported, patient is waiting for another surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: it was reported that hip revision surgery was performed.All of the implanted devices were used in treatment.The patient has supplied their available medical information, excluding medical records from ¿(b)(6) health¿.The implanted devices have been requested for this complaint but have not become available.A review of the complaint history for the bhr head and bhr cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were 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.A review of the product 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.The revision operative note indicated ¿aseptic failure right hip resurfacing arthroplasty¿ as the revision indicator.The laboratory reports from 2015 ¿ 2018 indicate that urine cobalt and chromium levels were within reference range.However, several other metal ion levels (magnesium, cesium, zinc, nickel, thallium, manganese, iron, mercury, lead, thallium, tin, and copper) were elevated.The revision operative note did not note findings consistent with metal related pathology.With the information provided, the clinical root cause of the reported pain, post revision elevated metal ion levels, tracheomalacia and optic neuropathy cannot be confirmed, and it cannot be concluded that the reported clinical events 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 the details supplied in this complaint.Therefore the investigation remains inconclusive and neither a definitive nor potential root cause can be determined.Based on the information provided we are unable to speculate on specific factors known to contribute to the alleged fault.If the products or additional information becomes 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: ACETLR CUP HAP 48MM W/ IMPTR
• Common Device Name: 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: 11462009
• Report Number: 3005975929-2021-00142
• Device Sequence Number: 14333322
• Product Code: NXT
• UDI-Device Identifier: 03596010502551
• UDI-Public: 03596010502551
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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 Model Number: 74120148
• Device Catalogue Number: 74120148
• Device Lot Number: 29503
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR