MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 58MM; PROSTH, HIP, SEMI-CONSTRAIN, UNCEMENT, MET/POLY, POROUS

Catalog Number 71335758

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/05/2020

Event Type  Injury  

Event Description

It was reported that the patient had an excellent recovery from the primary surgery ((b)(6) 2020), but about four weeks ago, developed a wound ooze which did not improve with wound care and antibiotics, so a washout was performed ((b)(6) 2020).The pathology revealed that it was pseudomonas and staphylococcus.Therefore, a revision surgery, washout and debridement was performed via the previous incision.The liner was removed.Surgeon stated that the hip was stable and that the patient health was satisfactory.

Manufacturer Narrative

It was reported that the patient developed a wound ooze which did not improve with wound care and antibiotics, so a washout was performed.The pathology revealed that it was pseudomonas and staphylococcus.The affected complaint, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.The device was sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical analysis noted that the symptoms (ooze) reportedly appeared approximately 2 weeks post implantation.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 58MM
• Type of Device: PROSTH, HIP, SEMI-CONSTRAIN, UNCEMENT, MET/POLY, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10109018
• MDR Text Key: 193314291
• Report Number: 1020279-2020-01932
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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: 71335758
• Device Lot Number: 18HM15301
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention