MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 38MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122538

Device Problem Biocompatibility (2886)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Metal Related Pathology (4530)

Event Date 08/31/2020

Event Type  Injury  

Event Description

*us legal mdl* it was reported that, after a tha metal-on-metal construct had been implanted on the plaintiff´s left hip on (b)(6) 2010, the plaintiff experienced metallosis consistent with failed metal on metal hip components.Due to severe metallosis, the plaintiff also had a trochanteric fracture.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.The plaintiff outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that revision surgery was performed on the patients left hip.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the head, r3 liner, modular sleeve and sphere head screw performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head and the sphere head screw.Other similar complaints have been identified for the modular sleeve and r3 liner, as these parts are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.With the information provided the clinical root cause of the reported pain and intraoperative findings of trochanteric fracture, cystic mass, and metal fragments cannot be confirmed and cannot be concluded that the events/clinical reactions were associated with a malperformance of the implant.The patient impact beyond the pain, revision, and expected transient post op convalescence period cannot be determined.Without additional information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.

• Brand Name: HEMI HEAD 38MM
• Type of Device: 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: 11910674
• MDR Text Key: 254272303
• Report Number: 3005975929-2021-00294
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071540
• UDI-Public: 885556071540
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Catalogue Number: 74122538
• Device Lot Number: 09AW21083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female