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

Catalog Number	74122554
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Metal Related Pathology (4530)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
Us legal: it was reported that, after a right bhr-tha was performed on (b)(6) 2011 due to hypertrophic osteoarthritis, the patient experienced elevated serum cobalt and chromium levels.Plaintiff underwent a left revision surgery on (b)(6) 2021 ((b)(4)).It is unknown if a right revision surgery has been performed.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Additional information added: a2 (date of birth), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that, after a right bhr-tha was performed the patient experienced elevated serum cobalt and chromium levels.As of today, the implanted devices, all of which were used in treatment are not accessible for testing.A review of the historical complaints data for the hemi head and modular sleeve was performed using batch numbers, part numbers and the reported failure mode to evaluate patterns of repeated failures or defects.Similar complaints have been identified for both devices.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.The hemi head and modular sleeve involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure mode.A risk management review was performed.The alleged failure mode 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.Although it was reported the serum cobalt and chromium levels were elevated, neither the levels nor laboratory reports were provided for review.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported elevated serum cobalt and chromium levels cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond the elevated serum metal ions cannot be determined.Based on the available information we cannot 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.Corrected data: h3, h6(health effect - clinical code).

• Brand Name: HEMI HEAD 54MM
• 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: 14140534
• Report Number: 3005975929-2022-00169
• Device Sequence Number: 3986033
• Product Code: KWL
• UDI-Device Identifier: 00885556071854
• UDI-Public: 885556071854
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K062408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2012
• Device Catalogue Number: 74122554
• Device Lot Number: 07JW13584
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2007
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71309115/SYN POR PLUS HA HO STEM SZ 15/11LM00383A; 74222200/MODULAR SLEEVE {} PLUS 0MM12/14/10DT41994
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown