MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 52MM; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY

Catalog Number	71331952
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to unspecified reasons (pain) to remove the stem and cup from the patient.No delay reported.
Additional Manufacturer Narrative
The associated reflection 3 hole shell and anthology porous plus high offset stem were not returned for evaluation.Therefore products evaluation could not be performed.After repeated requests, smith and nephew has been unable to obtain device details.Thus, a review of device history record could not be performed.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Our clinical evaluation noted that no relevant clinical supporting documents were provided to conduct a thorough medical assessment of the reported thigh and groin pain.Should additional relevant clinical information be provided this complaint will be re-assessed.Without the return of the actual product involved and no product information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 52MM
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8108722
• Report Number: 1020279-2018-02623
• Device Sequence Number: 2169344
• Product Code: JWH
• UDI-Device Identifier: 03596010194176
• UDI-Public: 03596010194176
• Combination Product (Y/N): N
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2019

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 Expiration Date: 09/23/2018
• Device Catalogue Number: 71331952
• Device Lot Number: 08JM18757
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 11/14/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 04/26/2019; 05/27/2019
• 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: PN 71303200 / BN 08JM18757; PN 71337652 / BN 07KM24717
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR