MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R ART INS SZ 3-4 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420492
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation of the insert the joint and sitting flat against the anterior proximal tibia.
Event or Problem Description
It was reported that patient had a revision surgery performed due to dislocation of the insert.X-rays showed the insert was fully dislocated from the joint and sitting flat against the anterior proximal tibia which was causing pain to the patient.As per information provided, patient had fallen downstairs when dislocation occurred.Patient was reported to have full mobility after surgery.
Additional Manufacturer Narrative
H10.H3, h6: the associated genesis ii c/r articular insert was returned and evaluated.A lab analysis conducted during this investigation indicated that the returned device was examined visually.No destructive analysis was performed.The examination noted damage/deformation was observed on the anterior region of the insert¿s articular surface.Damage and scratches were observed on the inferior surface of the device and deformation was also observed on the anterior surface of the insert.No material or manufacturing deviations were observed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical analysis noted that based on the information provided the revision surgery was performed due to a fall injury that was sustained by the patient and not a mal-performance of the implant.The impact to the patient beyond the revision cannot be concluded.It was communicated that the patient was reported to have full mobility after surgery.Should additional information be received, the complaint will be reopened and reevaluated.B5 updated.D4: lot number and expiration date provided.G5: 510k provided.H5: manufacturing date provided.

• Brand Name: GII C/R ART INS SZ 3-4 11MM
• 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: 8756534
• Report Number: 1020279-2019-02607
• Device Sequence Number: 2523460
• Product Code: JWH
• UDI-Device Identifier: 03596010207906
• UDI-Public: 03596010207906
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 71420492
• Device Lot Number: 18JT09028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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