MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN REFLECTION POLY LINER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 06/07/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after total hip replacement was performed on (b)(6) 2009, the patient experienced pronounced osteolysis in the area of the right acetabulum, pain and cracking noises in the right leg.This adverse event was treated with a revision surgery on (b)(6) 2022, in which fracture and complete wear and tear of the polyethylene inlay was observed.In addition, metallosis was observed on the socket; a sample was collected and test results remain pending.Patient is currently in severe pain and still unable to walk without crutches four months post-operative.

Manufacturer Narrative

Section h10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, it should be noted the acetabular osteophytes pre implant and pre-revision cannot be ruled out as contributing factors to the reported clinical reactions/ events.The reported pain, complete wear of the polyethylene inlay, and loosening of the acetabulum may be consistent with the reported metallosis but the root cause cannot be confirmed as it could also be seen as a result of the very large osteolysis, that could also lead to the reported loosening of the acetabulum and complete wear of the polyethylene inlay.The patient reports continued severe pain and the use of crutches for ambulation 4-months post-revision.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, patient medical history, adverse reaction, bone quality, irregular implant interaction and/or abnormal motion over time.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.Internal complaint reference number: (b)(4).

Manufacturer Narrative

Corrected data: d9, h3 (device returned to manufacturer), h6 (health effect - clinical code, health effect - impact code, type of investigation, investigation findings, investigation conclusions).Updated results of investigation: the associated device was returned and evaluated.A visual inspection reveals severe damage and wear to the devices.A lab analysis reveals the visual examination of the liner showed wear-related damage to the articular surface, being worn completely through.The liner was also fractured which may have been caused by extraction.The black discoloration found may have been caused by debris from the head contacting the shell.No evidence of deviation in processing or material was found for the retrieved items.Destructive testing was not performed during this examination.No definitive conclusions as to the cause of these issues can be determined.The clinical/medical evaluation concluded that it should be noted the acetabular osteophytes pre implant and pre-revision cannot be ruled out as contributing factors to the reported clinical reactions/ events.The reported pain, complete wear of the polyethylene inlay, and loosening of the acetabulum may be consistent with the reported metallosis but the root cause cannot be confirmed as it could also be seen as a result of the very large osteolysis, that could also lead to the reported loosening of the acetabulum and complete wear of the polyethylene inlay.The patient reports continued severe pain and the use of crutches for ambulation 4-months post-revision.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file, prior actions and product prints could review not be performed.At this time, we do not have 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 patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H10: upon confirmation with the product design team, it was found that reflection cups are not compatible with r3 liners nor competitor devices.We acquired knowledge that the reported liner must be a reflection polyethylene liner.H11-corrected data: d1- brand name.

• Brand Name: UNKNOWN REFLECTION POLY LINER
• 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: 15748469
• MDR Text Key: 303225223
• Report Number: 1020279-2022-04718
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/29/2022; 06/12/2023; 09/06/2023
• Supplement Dates FDA Received: 12/08/2022; 06/13/2023; 09/06/2023
• 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: UNKN. SL-PLUS STEM
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG