MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122542
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
Us legal, it was reported that the plaintiff underwent a second revision surgery of the left hip on (b)(6) 2019 due a metal related pathology.During the surgery, evidence of significant osteolysis and metalosis was found, and the metallic cup and femoral head were explanted.After the revision, the patient was diagnosed with ¿cobalt cardiomyopathy¿ and suffered severe complications related to progressive cardiogenic shock, acute renal failure with hyperkalemia, hyponatremia, and metabolic acidosis.This issue has not been resolved.
Additional Manufacturer Narrative
H3, h6: it was reported that a second left hip revision surgery was performed.During the revision, the acetabular cup, hemi head and modular sleeve were all explanted.The stem remained implanted.As of today, the explanted devices, all of which were used in treatment, have been requested for this complaint but have not become available.A review of the historical complaints data for the acetabular cup, hemi head, modular sleeve and stem was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Other similar complaints were identified to involve both this batch of acetabular cups and this batch of modular sleeves, however, as these devices are no longer sold, no action is to be taken.No other similar complaints were identified to involve these batches of hemi heads or stems.No other complaints have been identified for the part numbers and the reported failure modes in this timeframe.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 manufacturing records did not reveal any waivers, concessions, manufacturing, or material abnormalities that could have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.The devices used in treatment have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.A review of 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.Per the surgical technique, the acetabular component is to be impacted with 15-20 degree of anteversion and 40-45o inclination angle.However, the revision operative report indicated the acetabular component found to be vertical.The surgeon indicated that this position of the acetabular cup is most likely the source of metal ions.It is unknown if the vertical position of the acetabular component led to accelerated wear and the reported events.The patient impact beyond that which has already reported cannot be determined.Based on the information provided, we can confirm this complaint.Without return of the devices used in treatment or additional information, we cannot advance this investigation or determine a definitive root cause.Factors which are known to contribute to the alleged fault include excessive physical activity levels, excessive patient weight, and loosening of the components, increasing the production of wear particles, accelerating 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 42MM
• 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: 12681794
• Report Number: 3005975929-2021-00482
• Device Sequence Number: 11760100
• Product Code: KWL
• UDI-Device Identifier: 00885556070710
• UDI-Public: 885556070710
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 06/29/2013
• Device Catalogue Number: 74122542
• Device Lot Number: 08FW17358
• 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: 10/05/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2008
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71309015-SYN POR PLUS HA SO STEM SZ 15; 74222100-MODULAR SLEEVE -4MM 12/14; 71309015-SYN POR PLUS HA SO STEM SZ 15; 74222100-MODULAR SLEEVE -4MM 12/14
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female