MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 LINER CERAMIC POLY; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNKNOWN

Device Problems Degraded (1153); Biocompatibility (2886); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

Event Description

It was reported that on the literature review "liner dissociation leading to catastrophic failure of an oxinium femoral head", a patient underwent a bilateral tha in 2009, but continue to experience groin pain and limited range of motion in the left hip.In 2012, the patient had progressively worsening pain, ultimately requiring a walker.Radiographs in 2012 showed diffuse hyperdense findings, osteolysis with femoral head flattening and evident superior migration of the femoral component.A revision surgery was recommended but the patient declined.Patient's condition deteriorated over the next five years and in (b)(6) 2017, the patient underwent a revision surgery on the left hip in which an erosion of the femoral head against the metallic rim of the acetabular component was noted.The acetabular cup and the stem was loose and there was evidence of metallosis.The patient had a postoperative fever but eventually recovered.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that it cannot be determined to what extent the delayed surgical intervention had on the patients¿ pain and clinical status.Although the clinical root cause of the reported dissociated acetabular liner, subsequent metallosis and revision cannot be definitively confirmed; the reported summation of, ¿improper seating of the liner leading to liner dissociation was the most likely etiology leading to catastrophic failure¿ cannot be ruled out.The patient impact beyond the reported events cannot be confirmed nor concluded.No further clinical assessment is warranted at this time.Devices specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management files and prior actions review could not be performed.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include insertion technique, alignment, implants interaction and/or post-operative care.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.We consider this investigation closed.

• Brand Name: R3 LINER CERAMIC POLY
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 17171899
• MDR Text Key: 317596713
• Report Number: 1020279-2023-01346
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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?: Yes
• Date Manufacturer Received: 07/21/2023
• 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: FEM HEAD MEMPHIS OX (PN: UNKNOWN, LOT: UNKNOWN)
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female