MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 RT 9; PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR

Catalog Number	74023271
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to broken component.
Additional Manufacturer Narrative
The associated journey bcs articular insert was returned and evaluated.A lab analysis conducted during this investigation noted that abrasion, burnishing and deformation were observed in the bearing regions on the superior and the inferior surfaces 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.Based on these results, 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 initiated one or more fatigue cracks, which propagated in an anterior direction until final fracture occurred.A clinical evaluation noted that no relevant information has been provided to conduct a thorough medical investigation.The impact to the patient beyond the revision and any further risk to the patient cannot be concluded based on the information provided.Therefore, no further clinical/medical assessment is warranted at this time.However, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 7-8 RT 9
• Common Device Name: PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7646087
• Report Number: 1020279-2018-01222
• Device Sequence Number: 14023751
• Product Code: JWH
• UDI-Device Identifier: 03596010555274
• UDI-Public: 03596010555274
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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 Catalogue Number: 74023271
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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: Required Intervention; Disability