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

Catalog Number UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 08/05/2022

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr surgery had been performed on (b)(6) 2022, the patient experienced a liner disassociation.This adverse event was solved by a revision surgery on (b)(6) 2022.During the revision, it was found that the oxinium fem hd 12/14 32mm +0 was in contact with the r3 ti cup, which resulted in a high volume wear in the superior aspect of the head, also intra-articular metallosis was observed.A debridement with diathermy was performed, and it resulted in a few second audible and visible flame.There was no visible tissue damage, and the cup was revised with no other incidents.The current health status of patient is unknown.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation but the pictures were reviewed, and revealed that the femoral head and liner presented signs of extensive wear.However the dissociation of the liner and the alleged metallosis could not be confirmed.The clinical/medical investigation concluded that the provided photos do not provide insight into the clinical root cause of the reported event.As of the date of this medical investigation, additional supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events cannot be determined with the information provided.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include friction, joint tightness and/or surgical technique.The contribution of the devices to the reported incident could be corroborated as the device was damaged and it was required a revision surgery to treat this event.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.

• Brand Name: UNKN R3 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, TX 78735 ; 5123913905
• MDR Report Key: 15540230
• MDR Text Key: 301151539
• Report Number: 1020279-2022-04311
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: OXINIUM FEM HD 12/14 32MM +0, LOT#:21KM09360
• Patient Outcome(s): Hospitalization; Required Intervention