MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 1-2 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420802
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the insert could not be implanted.A delay of less than 30min reported.Delay time led to more bleeding.High buckling gasket was used to complete the surgery.
Additional Manufacturer Narrative
It was reported that during surgery the insert could not be implanted.A delay of less than 30 min was reported.The associated genesis ii ps insert was returned and evaluated.Visual inspection of the device showed minor damage on the locking detail.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.A clinical analysis noted that without the requested clinical information and the operative report, the root cause of the difficult implantation of the insert cannot be determined.However, a user vs procedural error cannot be ruled out.Beyond the excessive bleeding which required a blood transfusion, there is no further harm being alleged.There are no plans to do a revision and patient is reported as doing fine.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 relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
It was reported that during surgery the insert could not be implanted.A delay of less than 30 min was reported.The associated genesis ii ps insert was returned and evaluated.Visual inspection of the device showed minor damage on the locking detail.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.A clinical analysis noted that without the requested clinical information and the operative report, the root cause of the difficult implantation of the insert cannot be determined.However, a user vs procedural error cannot be ruled out.Beyond the excessive bleeding which required a blood transfusion, there is no further harm being alleged.There are no plans to do a revision and patient is reported as doing fine.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 relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GII PS INSERT SZ 1-2 9MM
• 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: 8844182
• Report Number: 1020279-2019-02860
• Device Sequence Number: 16203475
• Product Code: JWH
• UDI-Device Identifier: 03596010209504
• UDI-Public: 03596010209504
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2019

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: 71420802
• Device Lot Number: 18HM06241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019; 07/02/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 12/05/2019; 12/05/2019
• 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