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

Catalog Number	74122550
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Osteolysis (2377); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that after the plaintiff underwent a bhr right tha surgery on (b)(6) 2008, he experienced implant pain.A revision surgery was performed on (b)(6) 2022, in which the surgeon found that there was an extensive osteolysis of the greater trochanter with a rent in the anterior abductors.It was noticed that the hip joint had a cloudy milk consistent with metallosis.Also, there was extensive damage of the gluteus medius and abductors from the osteolysis.The anterior structures were certainly quite necrotic.It was found that the source of the metallosis was the trunnion.The modular head and sleeve were explanted and replaced for a bhr dual mobility liner and an oxinium head.The femoral neck was otherwise in good condition and no erosion of the periphery of the acetabular component was found; therefore, the acetabular and femoral component were not explanted.The procedure ended well but the patient has a high risk of dislocation due to the extensive necrosis of his abductors.
Additional Manufacturer Narrative
It was reported that a right hip revision surgery was performed due to pain, osteolysis, and metallosis.As of today, the explanted head and sleeve have not been returned for evaluation.The cup used in treatment, remains implanted and therefore cannot be tested.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 cup and the head, and this failure will continue to be monitored for the cup.This will continue to be monitored via routine trending for the head and the sleeve, 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 intraoperative findings of osteolysis, cloudy milk fluid, and extensive damage of the abductors may be consistent with findings associated with metallosis.The surgeon indicated it was evident that the source of the metallosis was the trunnion.However, the root cause of the trunnionosis cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a malperformance of the implant.The patient impact beyond the revision surgery cannot 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.

• 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: 17675078
• Report Number: 3005975929-2023-00122
• Device Sequence Number: 6285461
• Product Code: KWL
• UDI-Device Identifier: 00885556071205
• UDI-Public: 885556071205
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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 Catalogue Number: 74122550
• Device Lot Number: 10694
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/03/2023
• Supplement Report FDA Received Date: 09/26/2023
• 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 HEAD SLEEVE / 74222100
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male