MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKN01000000

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that after an unspecified primary thr surgery performed around 1997, the patient started experimenting pain around (b)(6) 2018 and in (b)(6) 2018, an x-ray confirmed erosion of the femoral component.In (b)(6) 2019, the patient underwent a revision surgery secondary to polyethylene wear debris, which caused osteolysis of the femur and femoral loosening.The stem, femoral head and liner were replaced.7 months later the patient underwent a second revision surgery due to a fracture of the newly implanted stem (covered under (b)(4)).

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, with the information provided the clinical root cause of the reported polyethylene wear debris, and subsequent osteolysis of the femur and femoral loosening cannot be definitively confirmed.However, aged, related wear was the likely cause the reported failure.We cannot rule out the patient¿s body habitus (morbid obesity bmi 42.48) and the cement breakage as contributing factors to the reported failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to friction, joint tightness, lifetime of device, patient condition or cement breakage.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 ORTHOPAEDIC RECONSTRUCTION DEV
• 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: 12828974
• MDR Text Key: 280887315
• Report Number: 1020279-2021-08211
• Device Sequence Number: 1
• Product Code: JDG
• 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: 02/22/2022

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: UNKN01000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 156 KG