MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 40/46; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74122146
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Cyst(s) (1800); Deformity/ Disfigurement (2360); Metal Related Pathology (4530)
Date of Event	06/30/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a primary bhr right hip surgery on (b)(6) 2007 and subsequently suffered from failed metal on metal.This adverse event was addressed by revision surgery on (b)(6) 2015 to exchange acetabular cup hap size 40/46 and femoral head 40mm.Furthermore, it was done acetabular reconstruction using extensive bone grafting, both patient's own bone and allograft femoral head reamings, and excision of pseudo-tumor granuloma.Also, excised the capsule and the pseudocapsule from around the joint in its entirety.Her wound was washed and dried, covered with sterile pressure dressing.Patient was transferred off the table on to a stretcher.She tolerated the procedure well.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that patient underwent a primary bhr right hip surgery and subsequently suffered from failed metal on metal.This adverse event was addressed by revision surgery.Furthermore, it was done acetabular reconstruction using extensive bone grafting, both patient's own bone and allograft femoral head reamings, and excision of pseudo-tumor granuloma.Also, excised the capsule and the pseudocapsule from around the joint in its entirety.Patient tolerated the procedure well.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.No other similar complaints have been identified for the cup and head.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 clinical root cause of the cyst cannot be confirmed.The acetabular placement 40 degrees abduction and 5 degrees anteversion cannot be ruled out as a possible contributing factor to the protrusio.The patient impact beyond the reported revision could not be determined.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.H6 (health effect - clinical code).

• Brand Name: ACETABULAR CUP HAP SIZE 40/46
• 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: 19520327
• Report Number: 3005975929-2024-00084
• Device Sequence Number: 17649894
• Product Code: NXT
• UDI-Device Identifier: 03596010565792
• UDI-Public: 3596010565792
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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?: No
• Device Catalogue Number: 74122146
• Device Lot Number: 8006
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74123140/FEMORAL HEAD 40MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female