MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120152
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a bhr resurfacing system left hip construct had been implanted on (b)(6) 2008, the plaintiff reported pain and lack of mobility.This is a bilateral patient, and a revision surgery of the right hip was performed on (b)(6) 2020 (covered under (b)(4)) due to a metal related pathology.Even though a revision surgery of the left hip has not been performed or scheduled, the contribution of the left hip construct can not be discarded as a contributor of the elevated cobalt and chromium levels in blood of the plaintiff.
Additional Manufacturer Narrative
It was reported that the bilateral patient reported pain and a lack of mobility.Elevated levels of cobalt and chromium were recorded.As of today, additional information has been requested for this complaint but has not become available.Left hip revision surgery was not performed, therefore, the devices, used in treatment, remain implanted.Without batch numbers a review of the manufacturing records could not be performed.Should the batch details be received at a later date this task will be reopened and completed.A review of the complaint history for the device was performed using the part number and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Other similar complaints were identified for the part number and the reported/related failure mode.This will continue to be monitored via routine trending, however it should be noted that this device is no longer sold.A full review could not be performed without batch numbers.A 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.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 quality escalations was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; no further escalation actions required.The available medical documents were reviewed.It should be noted the surgical technique indicates ¿the acetabular component is then fully impacted with 15-20° of anteversion and 40-45° inclination angle.¿ with the information provided the clinical root cause of the reported pain, lack of mobility and elevated ion levels cannot be confirmed and it cannot be concluded that reported events were associated with a mal-performance of the implant.It is also noted that preoperative metal ion levels were reportedly within the normal reference range.The patient impact beyond the pain cannot be determined.Based on the information provided we cannot further investigate the complaint our investigation remains inconclusive and 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, loosening of components may increase production of wear particles and accelerate damage to the bone.If the products or additional information become available in the future, this case will be reopened.Based on this investigation the need for corrective and preventative action is not indicated.

• Brand Name: ACETLR CUP HAP 52MM 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: 17060633
• Report Number: 3005975929-2023-00093
• Device Sequence Number: 8738981
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 3596010502575
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2023

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 Catalogue Number: 74120152
• Device Lot Number: UNKNOWN
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/07/2023
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2745 & Z-2746
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female