MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF STEM WITH STIKTITE SZ 2; PRSTHSS,HP,SM-CNSTRND,MTL/PLYMR,POROUS UNCMNTD

Catalog Number	71352502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	09/02/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a deep post operative infection (ecoli) and a revision surgery was performed to remove all components.
Additional Manufacturer Narrative
It was reported that the patient had a deep post-operative infection and a revision surgery was performed to remove all components.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.As no device batch numbers were provided for investigation, a manufacturing record review, complaint history review, device labelling / ifu review and risk management review could not be performed.If more information is received, this investigation will be reopened.No medical documents were received.Without the supporting lab results, imaging, medical reports and the analysis of the explanted components, the trunnionosis and metallosis cannot be confirmed and it cannot be concluded that the reported events reactions were associated with a mal-performance of the implant.The patient impact beyond the revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: SMF STEM WITH STIKTITE SZ 2
• Common Device Name: PRSTHSS,HP,SM-CNSTRND,MTL/PLYMR,POROUS UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10160690
• Report Number: 1020279-2020-02445
• Device Sequence Number: 19796589
• Product Code: LPH
• UDI-Device Identifier: 03596010619587
• UDI-Public: 3596010619587
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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 Catalogue Number: 71352502
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/19/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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
• Patient Weight: 73