MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 40MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122540
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Metal Related Pathology (4530)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the plaintiff underwent a revision surgery of the right hip due to elevated cobalt and chromium levels in blood, and wear of articular bearing system.During the revision surgery, the metallic cup, modular femoral head, and modular sleeve were explanted and replaced with a competitor´s system.The primary stem was not explanted.Intraoperative findings included a small pseudocyst in the lateral region, and reactive synovitis to the synovium of the joint.The patient was taken to the recovery room in stable condition.The primary bhr tha surgery was performed on (b)(6) 2009.
Additional Manufacturer Narrative
Complaint reference number: case (b)(4).
Additional Manufacturer Narrative
D10: concomitant medical products and therapy dates and g5: pma/510(k)number.Section h3, h6:it was reported that the plaintiff underwent a revision surgery of the right hip due to elevated cobalt and chromium levels in blood, and wear of articular bearing system.During the revision surgery, the metallic cup, modular femoral head, and modular sleeve were explanted and replaced with a competitor´s system.The primary stem was not explanted.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 head, sleeve and cup was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.No similar complaints have been identified for any of the concerned devices.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 elevated cobalt and chromium, pseudotumor, and reactive synovitis 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 40MM
• 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: 16957874
• Report Number: 3005975929-2023-00091
• Device Sequence Number: 17452672
• Product Code: KWL
• UDI-Device Identifier: 00885556070116
• UDI-Public: 885556070116
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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: 03/30/2013
• Device Catalogue Number: 74122540
• Device Lot Number: 08CW16076
• 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: 06/08/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2008
• 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
• 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: ACETABULAR CUP HAP SIZE 40/48, LOT#:07HW13418.; MODULAR SLEEVE {} PLUS 0MM 12/14, LOT#:07LW14556.; SYN POR PLUS HA SO STEM SZ 12, LOT#:08GM00434A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female