MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 METAL LINER IMPL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

*us legal* it was reported that, after reduction of a left hip fracture and internal fixation with advanced djd and avascular necrosis, plaintiff underwent a left tha on (b)(6) 2007 with implants from another manufacturer.Plaintiff underwent revision surgery on (b)(6) 2011 due to pain and loosening of the acetabular component, where smith+nephew components were implanted.Plaintiff underwent a second revision surgery on (b)(6) 2021 due to failed left tha and suspected high ion levels.The status of the plaintiff is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the 2nd revision operative note, the ¿metallosis noted upon exposure with abscess around the femoral head and trunnion¿ most likely supports involvement and/or mechanical failure at the site of the competitor femoral mod-components and head/¿trunnionosis¿; however, this cannot be definitively concluded.The s+n acetabular component was ¿removed with minimal bone loss¿ without supporting documentation of any s+n component malperformance.The s+n total hip systems ifu does warn not to mix components from different manufacturers; therefore, a user variance and off-label use cannot be ruled out as potential contributing factors to the reported event.The patient impact beyond the ¿failed tha¿ with ¿metallosis¿, abscess and ¿trunnionosis¿ noted around the competitor components, the off-label/mixed manufacturer construct, and subsequent revision with an anticipated post-operative convalescence phase cannot be determined.No further medical assessment can be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include user variance, damaged product or off-label use, damaged product, implant corrosion or wear.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN R3 METAL LINER IMPL
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin ; 5123913905
• MDR Report Key: 14493951
• MDR Text Key: 292576022
• Report Number: 1020279-2022-02579
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/04/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 07/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male