MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 1-2 9MM; PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR

Catalog Number	71421501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.
Additional Manufacturer Narrative
The associated genesis ii ps high flexion insert was returned and evaluated.A clinical evaluation noted that without supporting clinical/medical documents a thorough investigation cannot be performed.A lab analysis conducted during this investigation noted that lock detail deformation and scratches are observed on the inferior surface of the insert.The exact cause could not be determined from the investigation of the device.There were no observations of material or manufacturing deviations in the course of this investigation.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing or product specifications for the listed batch did not reveal abnormalities that could have contributed to the reported issue.No further investigation warranted for this complaint; 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: GII PS HIGH FLEXION INSERT SZ 1-2 9MM
• Common Device Name: PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7569904
• Report Number: 1020279-2018-01063
• Device Sequence Number: 16584060
• Product Code: JWH
• UDI-Device Identifier: 03596010492388
• UDI-Public: 03596010492388
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 71421501
• Device Lot Number: 16JT75456
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 11/08/2018
• 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