MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/60; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122160
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Toxicity (2333); Injury (2348); Test Result (2695); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that he has pain in both left and right hip bhr resurfacing areas.He has been diagnosed with high levels of cobalt and chromium in blood.Current levels: cobalt 397 nmol/lv and chromium 192 nmol/v.This complaint is for the right hip.Surgeon recommended revision surgery.
Additional Manufacturer Narrative
It was reported that a surgeon recommended revision surgery of the right hip, after reported elevated metal ion levels.As of today, additional information has been requested for this complaint but has not become available.All implanted devices were used in treatment.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.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.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.As of today, medical documents have not been made available for this complaint.Without further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be re-opened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.
Event or Problem Description
It was reported by the patient that he has pain in both left and right hip bhr resurfacing areas.He has been diagnosed with high levels of cobalt and chromium in blood.The right hip was revised on (b)(6) 2020.The complete bhr system was replaced by a tha system.The primary procedure was performed on (b)(6) 2016.

• Brand Name: ACETABULAR CUP HAP SIZE 52/60
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone ; 0447940038246
• MDR Report Key: 8994723
• Report Number: 3005975929-2019-00321
• Device Sequence Number: 365864
• Product Code: NXT
• UDI-Device Identifier: 03596010552327
• UDI-Public: 03596010552327
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2024

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: 74122160
• Device Catalogue Number: 74122160
• Device Lot Number: 09CW22247R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 10/03/2024
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 05/06/2020; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMORAL HEAD 52MM/ 74123152/14MW04451; FEMORAL HEAD 52MM/ 74123152/14MW04451
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male