MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 13; PRSTHSS, HP, SM-CNSTRND, NCMNTD, MTL/PLYMR, NN-PRS, CLCM-PHSPHT

Catalog Number	71309013
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	05/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thr the stem went further than the broach.Surgeon had to go up to a size 15 synergy from a 13.Les than 30 minutes delay reported, and a backup device was available.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.There were no visual abnormalities.Dimensional evaluation was completed on the returned femoral stem device.The device was fully inspected for the proximal, distal, and porous beaded profiles.No deviations were noted during inspection.The failure mode cannot be confirmed via dimensional inspection of the returned stem.The clinical/medical evaluation concluded that this complaint from the united states reports that the ¿stem went further than the broach¿.This required going up to a size 15 synergy stem from a size 13.Reportedly, there was no harm to the patient, less than 30 minutes delay, and a backup device was available to complete the procedure.Smith and nephew has not received adequate materials, to fully evaluate, the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: SYN POR PLUS HA SO STEM SZ 13
• Common Device Name: PRSTHSS, HP, SM-CNSTRND, NCMNTD, MTL/PLYMR, NN-PRS, CLCM-PHSPHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10122972
• Report Number: 1020279-2020-02005
• Device Sequence Number: 2851156
• Product Code: MEH
• UDI-Device Identifier: 03596010459688
• UDI-Public: 3596010459688
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K002996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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 Catalogue Number: 71309013
• Device Lot Number: 19LM17047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention