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 Codes	Malposition of Device (2616); Biocompatibility (2886)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
*us legal* it was reported that, after a bhr resurfacing construct had been implanted on the patient¿s right hip on (b)(6) 2007, the patient experienced pain, metallosis and prosthesis failure.This adverse event was treated with a revision surgery on (b)(6) 2021.During this procedure, the bhr femoral head was excised and removed.Intra-operatively, the acetabular component was well fixed but poorly positioned in slight retroversion, and the surgeon elected to revise it as well.Cancellous allograft was utilized to fill in some of the acetabular defects from the metal-on-metal reaction.A full tha system from a competitor¿s brand was implanted in exchange.The patient tolerated well the procedure and was transferred to the pacu unit in stable condition.
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 not been returned 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.Other similar complaints have been identified for the part number and the reported failure mode, 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.All released devices involved met manufacturing specifications 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.It should be noted the acetabular component was implanted with 30 degrees abduction (which is known to reflect the inclination).The surgical technique (01/07 4567-0103) indicates, ¿the acetabular component is then fully impacted with 15-20° of anteversion and 40-45° inclination angle.¿ it is unknown if the decreased abduction and/ or poorly positioned in slight retroversion angle of the acetabular component led to the reported pain, milky fluid, and scar tissue.It cannot be concluded the reported events/ clinical reactions were associated with an implant malperformance or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the available information we can confirm this complaint, a probable root cause of the reported issues is the deviation from the surgical technique and not the device.Other 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 device be received, the complaint 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: 14487240
• Report Number: 3005975929-2022-00326
• Device Sequence Number: 20017507
• 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: 2007
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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 Model Number: 74120158
• Device Catalogue Number: 74120158
• Device Lot Number: 077492
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 07/28/2022
• 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; Other
• Patient Age: 62 YR
• Patient Sex: Male