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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 58MM; PROSTH, HIP, SEMI-CONSTRAIN, UNCEMENT, MET/POLY, POROUS Back to Search Results
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.
 
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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 Key10109018
MDR Text Key193314291
Report Number1020279-2020-01932
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
PMA/PMN Number
K113848
Number of Events Reported1
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 Number71335758
Device Lot Number18HM15301
Initial Date Manufacturer Received 05/05/2020
Initial Date FDA Received06/02/2020
Supplement Dates Manufacturer Received08/11/2020
Supplement Dates FDA Received09/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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