MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO STEM 190MM SZ 18 SO; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	71354467
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.Lysis was noted at the back of the cup and a membrane was formed around stem.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to infection.Lysis was noted at the back of the cup and a membrane was formed around stem.The affected redapt femoral standard offset sleeveless stem and r3 multi-hole ha coated hemispherical shell, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.The devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: REDAPT SLVLS MONO STEM 190MM SZ 18 SO
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9105717
• Report Number: 1020279-2019-03455
• Device Sequence Number: 1971927
• Product Code: LZO
• UDI-Device Identifier: 00885556580615
• UDI-Public: 00885556580615
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71354467
• Device Catalogue Number: 71354467
• Device Lot Number: 17ETM0146A
• Initial Date Received by Manufacturer: 08/25/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P#71303604 L#18KM24850; P#71335758R3 L#18MM03277
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention