MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT 9; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	74023261
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	02/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the pin broke.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.Visual inspection of the product shows abrasion, burnishing and deformation were observed in the bearing regions on the superior surface of the insert.The ps post was fractured near the mid height of the post.Significant deformation was observed on the posterior surface of the ps post and was likely caused by repeated contact with the femoral cam combined with excessive loads.From a lab analysis conducted during this investigation, it is concluded that the likely cause of this fracture may have been due to repeated posterior impingement of the femoral cam on the ps post combined with excessive loads.The resultant damage on the posterior face of the ps post likely created a stress concentration that likely initiated one or more fatigue cracks, which propagated in an anterior direction until final fracture occurred a clinical investigation concluded that no clinically relevant documentation was provided to perform a thorough medical investigation; the patient impact beyond the revision surgery itself cannot be determined.No further medical assessment is warranted at this time.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed part revealed no additional complaints for this failure mode with the same batch number.No further actions are being taken at this time.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 5-6 LT 9
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7280880
• Report Number: 1020279-2018-00202
• Device Sequence Number: 1342521
• Product Code: JWH
• UDI-Device Identifier: 03596010555205
• UDI-Public: 03596010555205
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2018

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: 11/27/2016
• Device Catalogue Number: 74023261
• Device Lot Number: 06LM10816
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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: 75 YR