MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/56; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122156
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Memory Loss/Impairment (1958); Pain (1994); Metal Related Pathology (4530)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after right bhr was performed on (b)(6) 2020 due to right hip arthritis, the patient experienced pain in groin, high ion levels and short-term memory issues.This adverse event was treated with a revision surgery on (b)(6) 2020, in which an acetabular component in retroversion and slight metallosis to the tissue were noticed.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, have been requested but have not become available.As no device batch numbers were provided for investigation, a manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the devices involved.A review of historical complaints data was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaint has been identified for the part number and the reported failure mode for the acetabular cup.Other similar complaints have been identified for the part number and the reported failure mode for the femoral head, and this failure will continue to be monitored.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.The reported pain, elevated metal ions, and intraoperative finding of the retroverted acetabular component can be seen as a result of metallosis, but changes in position could also accelerate wear and lead to metal debris and result in metallosis.With the information provided, the root cause of the reported pain, elevated metal ions, and metallosis cannot be confirmed.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.Based on the information provided we can confirm the alleged complaint, however without further information a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: ACETABULAR CUP HAP SIZE 48/56
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14029329
• Report Number: 3005975929-2022-00126
• Device Sequence Number: 5669068
• Product Code: NXT
• UDI-Device Identifier: 03596010552303
• UDI-Public: 03596010552303
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2022

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: 74122156
• Device Catalogue Number: 74122156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 07/29/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/31/2022; 07/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 59 YR
• Patient Sex: Male