MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO STEM 190MM SZ 19 SO; PROSTHESIS, HIP, SEMI-CNSTRND, METAL/CERAMIC/POLY, CMNTD OR NON-POROUS, UNCMNTD

Model Number	71354468
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after the second surgery due to the fracture on august 2020 the patient got infected therefore it was done a revision surgery on 01/07/2021.All implants were removed.( oxinium fem hd 12/14 36 mm -3, redapt slvls mono stem 190mm sz 19 so, r3 3 hole acet shell 58mm, r3 20 deg xlpe acet lnr 36mm x 58mm, two ref spher head screw 20mm, three acc 2.0mm cocr cable w/clamp.) those implants were replaced, excepted for the flexible osteotomes used to remove the redapt slvls mono stem 190mm sz 19 so and also was implanted four cc 2.0mm cocr cable w/clamp.Patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a 2nd thr revision was required due to infection approximately 4 months s/p the 1st revision (for a periprosthetic fracture which occurred approximately two months post implantation).Reportedly, all implants were removed for a 1st-stage revision.S+n has not received adequate information/documentation to fully evaluate the root cause of the reported event as responses to the medical documentation requests have not been provided as of the date of this assessment.The root cause was reportedly an unspecified infection secondary to the periprosthetic fracture.The patient impact beyond the reported infection and subsequent 1st-stage revision (explanted tha components and cerclage removal) could not be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 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, 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: REDAPT SLVLS MONO STEM 190MM SZ 19 SO
• Common Device Name: PROSTHESIS, HIP, SEMI-CNSTRND, METAL/CERAMIC/POLY, CMNTD OR NON-POROUS, UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11263409
• Report Number: 1020279-2021-00822
• Device Sequence Number: 11067412
• Product Code: LZO
• UDI-Device Identifier: 00885556580622
• UDI-Public: 00885556580622
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 71354468
• Device Catalogue Number: 71354468
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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: 71332520; 71332520; 71340007; 71340007; 71340007
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR