MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN01000000

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Necrosis (1971); Pain (1994); Osteolysis (2377)

Event Date 04/12/2022

Event Type  Injury  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

It was reported that the plaintiff underwent a revision surgery on (b)(6) 2022 due to a mechanical failure of the right tha with fracture of the femoral component.During the revision, a fair amount of grey appearing necrotic tissue was found around the proximal femur and articulation of the joint itself with a large erosive area of osteolysis through the lateral trochanter.All the tha components were explanted during the revision surgery, except for the acetabular cup, which was very well fixed.The patient was transferred to the recovery room in stable condition.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation, however the clinical/medical investigation concluded that x-rays taken at the clinic demonstrated a fracture of the femoral stem through the sleeve portion of the construct.Patient was placed on non-weightbearing protocol until the revision was performed.The surgeon noted in the revision operative report the following findings: gray appearing necrotic tissue, a large erosive area of osteolysis, fracture of the trochanter through the large erosive area laterally, and the broken proximal portion on the femoral stem.Per the revision operative report, only the acetabular cup was retained and a s+n oxinium dual mobility liner and femoral head along with another manufacturer¿s stem were implanted.The procedure was noted to be complex and prolonged 30-45 minutes due to the need for specialized osteotomy and femoral cortical strut grafting.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.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 traumatic injury, size selected, surgical technique or postoperative care.The contribution of the device 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.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 ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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: 15834668
• MDR Text Key: 304020348
• Report Number: 1020279-2022-04797
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male