MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74121154
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/12/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference number: case (b)(4).
Event or Problem Description
Legal it was reported that after a left bhr surgery performed on (b)(6) 2007, due to osteoarthritis, the plaintiff started to experience increasing pain and x-rays showed loosening of the femoral side with impingement.A revision surgery was performed on (b)(6) 2011 where the resurfacing femoral head was removed, and the cup was kept.Patient tolerated the procedure well and was taken to post-anesthesia care in good condition without complications.
Additional Manufacturer Narrative
H3, h6: it was reported that a left hip revision surgery was performed due to increasing pain and x-rays showing loosening of the femoral side with impingement.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 devices concerned 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 femoral head and the acetabular cup, 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.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, no prior applicable escalation actions were identified.The available medical documents were reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20 degree of anteversion and a 40-45 degree inclination angle.However, the implantation operative report noted the final position of the acetabular component as being 20 to 25 degrees of anteversion as well as having 4 to 8 mm of under coverage.It is unknown if this position of the acetabular component along with the under coverage of the femoral head has led to the reported loosening and impingement of the femoral component.Additionally, the patient¿s previous trochanteric osteotomy cannot be ruled out as a contributing factor to the reported event as the bhr ifu precautions previous hip surgery such as osteotomy, core decompression, hemi-resurfacing, or internal fixation may increase the risk of early failure.The impact to the patient beyond the revision surgery cannot be determined based on the lack of 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 muscle and fibrous tissue laxity and malpositioning of the implants leading to postoperative joint instability.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: RESURFACING FEMORAL HEAD 54MM
• 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: 16957619
• Report Number: 3005975929-2023-00088
• Device Sequence Number: 7168283
• Product Code: NXT
• UDI-Device Identifier: 03596010502803
• UDI-Public: 03596010502803
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2012
• Device Model Number: 74121154
• Device Catalogue Number: 74121154
• Device Lot Number: 74377
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/16/2023
• Date Device Manufactured: 04/30/2007
• 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
• Patient Age: 41 YR
• Patient Sex: Male