MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 58MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	02/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
Us legal: it was reported that the plaintiff underwent a medically indicated revision surgery of the right hip due to an infection on (b)(6) 2021.The patient had an aspiration with gram-positive cocci noted.During the revision surgery, both bhr components were explanted and replaced with antibiotic spacers.The patient was hospitalized for continuous iv antibiotics therapy.The outcome of the patient is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
*us legal* it was reported that the plaintiff underwent a medically indicated revision surgery of the right hip due to an infection on (b)(6) 2021.The patient had an aspiration with gram-positive cocci noted.During the revision surgery, both bhr components were explanted and replaced with antibiotic spacers.The patient was hospitalized for continuous iv antibiotics therapy.The outcome of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that a right hip revision surgery was performed.As of today, the implanted devices, which were all used in treatment have been requested for this complaint but have not become available for evaluation.A review of the historical complaints data for the acetabular cup and femoral head was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and 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 complaints were identified to involve this batch and for the part number and the reported failure mode.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.It was also confirmed that the product met manufacturing sterility requirements upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.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.No further actions are required at this time.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 infection and subsequent revision were noted to have been related to ¿gram-positive cocci,¿ which is highly likely of an exogenous nature.There is no evidence the infection and subsequent revision are related to a malperformance of the implant.The patient impact beyond the infection, revision, and expected transient post-op convalescence period cannot be determined.Based on the available information we can confirm the reported complaint, however without further information our 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 additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: ACETLR CUP HAP 58MM 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
• 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: 13927160
• Report Number: 3005975929-2022-00087
• Device Sequence Number: 1713943
• Product Code: NXT
• UDI-Device Identifier: 03596010502605
• UDI-Public: 03596010502605
• 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: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2018
• Device Model Number: 74120158
• Device Catalogue Number: 74120158
• Device Lot Number: 13HW12343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 03/04/2022; 05/04/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 03/28/2022; 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male