MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 13MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/METAL/POLY

Catalog Number	71453113
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to reduced range of motion.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no clinical supporting documents were provided to conduct a thorough analysis of the reported issue.No medical assessment can be rendered.Should relevant clinical documents be provided this case will be re-assessed.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 3-4 13MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8191909
• Report Number: 1020279-2018-02876
• Device Sequence Number: 11269251
• Product Code: JWH
• UDI-Device Identifier: 00885556034538
• UDI-Public: 00885556034538
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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: 71453113
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 04/05/2019
• 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