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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Dislocation (2374); Metal Related Pathology (4530)

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).Mastel, m., boisvert, a., moore, r., sutherland, f., & powell, j.(2022).Metallosis following hip arthroplasty: two case reports.Journal of medical case reports, 16(1), 1-9.Doi: https://doi.Org/10.1186/s13256-022-03336-4.

Event Description

"it was reported that on literature review ""metallosis following hip arthroplasty: two case reports"", one patient had a primary right hip tha surgery with a r3 acetabular shell, r3 poly liner, synergy stem and cocr femoral head.8 years after the primary surgery, the patient suffered from a dislocation and one year later, the patient sustained a second dislocation.The patient exhibited signs of metallosis and underwent a revision surgery to treat the adverse event.At 6 weeks follow-up, the patient was recovering well.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that no conclusions can be made from this publication as its limited to the information provided and further investigation is not possible.It was reported that at the 6 weeks follow-up, the patient was recovering well.No further clinical assessment is warranted 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.Possible causes could include but not limited to traumatic injury, patient anatomy, abnormal loading of limb, 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 LINER CERAMIC POLY
• 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: 14450768
• MDR Text Key: 292163613
• Report Number: 1020279-2022-02438
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• 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
• Treatment: UNKN SYNERGY HIP STEM CEM
• Patient Outcome(s): Hospitalization; Required Intervention