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

Catalog Number 74120152

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that the plaintiff underwent a primary left bhr-tha on (b)(6) 2011 and subsequently suffered from left hip pain and metallosis.This adverse event was addressed by revision surgery on (b)(6) 2023.The acetabular component was noted to be grossly loose, the femoral component was noted to be well-fixed.Multiple tissue samples were taken, which all appeared to be consistent with infection.The acetlr cup hap 52mm w/ imptr, modular sleeve plus 0mm (b)(6), syn por plus ha ho stem sz 15 and hemi head 46mm were explanted.The hip was again noted to be stable throughout the range of motion and with acceptable leg lengths.The patient was transferred to the recovery room.No active abduction with posterior hip precautions.

Manufacturer Narrative

H3, h6: it was reported that the patient underwent a primary left bhr total hip arthroplasty and subsequently suffered from left hip pain and metallosis.This adverse event was addressed by revision surgery.The acetabular component was noted to be grossly loose, the femoral component was noted to be well-fixed.Multiple tissue samples were taken, which all appeared to be consistent with infection.The acetlr cup hap 52mm w/ imptr, modular sleeve {} plus 0mm 12/14, syn por plus ha ho stem sz 15 and hemi head 46mm were explanted.The hip was again noted to be stable throughout the range of motion and with acceptable leg lengths.The patient was transferred to the recovery room.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 alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the head and cup and no other similar complaints have been identified for the sleeve and stem.This will continue to be monitored via routine trending, however it should be noted that these devices are no longer sold.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.The 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, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.The birmingham hip surgical technique (10/10 rev a (b)(4)) indicates, ¿sequential reaming with hemispherical acetabular reamers is then performed and in normal consistency bone, reaming proceeds to 2mm less than the definitive acetabular component to be inserted.However, the implantation operative report indicated the acetabulum was reamed up to a size 52 and a 52mm component was inserted.It cannot be determined to what extent the under-reaming had on the patients clinical status.The periprosthetic infection 11.5 years post implantation is highly likely of an exogenous nature and is not related to the implant.The reported loosening of the acetabular cup could accelerate wear and lead to metal debris and result in metallosis; however, the metallosis could lead to the loosening of the acetabular cup as could the infection.The reported ¿pain and elevated metal ions, may be consistent with the reported metallosis; however, the clinical root cause of the pain and elevated metal ions cannot be definitively confirmed related to metal debris or the infection.It cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the revision cannot be determined with the provided information.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.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.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: ACETLR CUP HAP 52MM W/ IMPTR
• Type of Device: 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: 17935113
• MDR Text Key: 325675137
• Report Number: 3005975929-2023-00147
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 3596010502575
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 74120152
• Device Lot Number: 10JW29796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71309115/SYN POR PLUS HA HO STEM SZ 15; 74122546/HEMI HEAD 46MM; 74222200/MODULAR SLEEVE {} PLUS 0MM 12/14
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male