MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ3 RIGHT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420182
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to osteolysis.All implants were exchanged to (b)(4) products.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and it has been communicated via email that there is no relevant supporting clinical information available at this time, and the patient has recovered.Therefore based on insufficient information, no further clinical assessment can be performed at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ3 RIGHT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8704293
• Report Number: 1020279-2019-02297
• Device Sequence Number: 2386391
• Product Code: JWH
• UDI-Device Identifier: 03596010206336
• UDI-Public: 03596010206336
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

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 Catalogue Number: 71420182
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 11/01/2019
• 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 Age: 69 YR