MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122546
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Metal Related Pathology (4530)
Date of Event	05/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, after a total right hip arthroplasty using a bhr system with corail stem on (b)(6) 2010 due to arthrosis, the plaintiff started to experience pain in the operated hip.This event was solved via revision surgery on (b)(6) 2022, in which necrotic tissue and dark fluid indicative of an adverse local tissue reaction secondary to metal wear and/or corrosion was noted.All the components of the primary surgery were explanted and replaced with a competitor's system.After the procedure, the patient was awakened from anesthesia and taken to the post anesthesia care unit (pacu) in stable condition.
Additional Manufacturer Narrative
It was reported that a right hip revision surgery was performed due to pain, necrotic tissue, dark fluid indicative of an adverse local tissue reaction secondary and metal wear and/or corrosion.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 cup and the head.This will continue to be monitored via routine trending, however it should be noted that this device is 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 information provided, of necrotic tissue, dark fluid, corrosion products around the trunnion and large osteolytic defect may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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 46MM
• 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: 16569498
• Report Number: 3005975929-2023-00019
• Device Sequence Number: 14822971
• Product Code: KWL
• UDI-Device Identifier: 00885556071588
• UDI-Public: 885556071588
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2014
• Device Catalogue Number: 74122546
• Device Lot Number: 09BW04012
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/18/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2009
• 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: A
• 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: 74120152 / 098896; 74222100 / 07LW14954
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female