MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120150
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Loss of Range of Motion (2032); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, on (b)(6) 2008, a plaintiff underwent a right bhmh procedure, due to an unstable slipped sub capital femoral epiphysis.Then in 2023 plaintiff complained of worsening right hip pain, difficulty with single leg stance, going up stairs, squatting, and right-side weakness.An x-ray found significant osteolysis around the acetabulum and femur, concerning for metallosis; and later blood work showed severely elevated cobalt and chromium levels.Therefore, a revision surgery was performed on (b)(6) 2023.Patient's outcome is unknown.
Additional Manufacturer Narrative
It was reported that a right hip revision surgery was performed due to right hip pain, difficulty with single leg stance, going up stairs, squatting, weakness, osteolysis, and elevated cobalt and chromium levels.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 cup and the head, but no similar complaints have been found for the sleeve.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.As of the date of this medical investigation, the requested supporting clinical documentation has not been provided; therefore, a clinical root cause of the reported events/clinical reactions cannot be confirmed.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.
Additional Manufacturer Narrative
H10.Additional information added in b5, b6, b7 and h6.
Event or Problem Description
It was reported that, on (b)(6) 2008, a plaintiff underwent a right bhmh procedure, due to an unstable slipped sub capital femoral epiphysis.Then in 2023 plaintiff complained of worsening right hip pain, difficulty with single leg stance, going up stairs, squatting, and right-side weakness.An x-ray found significant osteolysis around the acetabulum and femur, concerning for metallosis; and later blood work showed severely elevated cobalt and chromium levels.An aspiration was performed on (b)(6) 2023.A revision surgery was performed on (b)(6) 2023 with dual mobility xlpe insert, oxinium 28mm, 12/14 taper femoral head.Also noted was an intraoperative staph infection.Patient had post revision antibiotics via picc line for 6 weeks, with wound vac.Patient's outcome is unknown.
Additional Manufacturer Narrative
Additional information: d10, h6 (type of investigation and investigation conclusions) ,h10 (results of investigation).H3, h6: it was reported that a right hip revision surgery was performed due to right hip pain, difficulty with single leg stance, going up stairs, squatting, weakness, osteolysis, and elevated cobalt and chromium levels.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 cup and the head, but no similar complaints have been found for the sleeve.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.A clinical root cause could not be determined.Although the clinical reactions are consistent with findings associated with metal debris, intraoperatively the patient had no obvious signs of metallosis fluid and no wear of implants.There is a likely root cause: infection is highly likely of an exogenous nature and the pneumonia cannot be ruled out as a possible contributing factor.The patient impact is determined to be the revision and post-operative antibiotics.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 50MM 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: 18437001
• Report Number: 3005975929-2024-00001
• Device Sequence Number: 12518509
• Product Code: NXT
• UDI-Device Identifier: 03596010502568
• UDI-Public: 3596010502568
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/16/2024

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: 74120150
• Device Lot Number: 75049
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 01/25/2024; 04/05/2024; 04/10/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/26/2024; 04/12/2024; 04/16/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2746-2015
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71357005/ANTHOLOGY SO POR PL HA SZ 5.; 74122542/HEMI HEAD 42MM.; 74222400/MODULAR SLEEVE +8MM 12/14.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male