MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	74122550
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Metal Related Pathology (4530); Solid Tumour (4552)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after right bhr-tha surgery was performed on (b)(6) 2007, the patient experienced increased pain, swelling, adverse local tissue reaction, elevated metal ions levels and pseudotumor anteriorly.This adverse event was treated with a revision surgery on (b)(6) 2021.During the surgery, the hemi head and the modular sleeve were explanted.Patient's current health status is unknown.
Additional Manufacturer Narrative
It was reported that a right hip revision surgery was performed.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 hemi head.Similar complaints have been identified for the sleeve.However, as the devices are no longer sold, no action is to be taken.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.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 required.The available medical documents were reviewed.It should be noted the acetabular component was impacted into its final position in 40 degrees abduction inclination and 50 degrees anteversion.The surgical technique (01/07 4567-0103) indicates, ¿the acetabular component is then fully impacted with 15-20° of anteversion and 40-45° inclination angle.¿ it is unknown if the increased anteversion of the acetabular component led to accelerated wear and the elevated metal ions, adverse tissue reaction and corrosion at the head trunnion interface.It cannot be concluded the reported events/ clinical reactions were associated with an implant malperformance or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the available information we can confirm the reported complaint, however without further information 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.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: HEMI HEAD 50MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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: 14545086
• Report Number: 3005975929-2022-00369
• Device Sequence Number: 17382736
• Product Code: KWL
• UDI-Device Identifier: 00885556071205
• UDI-Public: 00885556071205
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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 Expiration Date: 01/01/2012
• Device Model Number: 74122550
• Device Catalogue Number: 74122550
• Device Lot Number: 10591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 09/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MODULAR SLEEVE -4MM 12/14, LOT#:07FW11732; SYN POR FEM COMP SZ 18, LOT#:03AM03954
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male