MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #7 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	82-7-0712
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Scorpio knee surgery: insert tibial 7x12mm ps.When trying to place it and hit it; insert not entered to the tibial tray.Wire was outside of its original position, and not allowed to "fall" in the tibial tray so we had to put another insert less thick.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a scorpio insert was reported.The event was not confirmed.Method & results: -device evaluation and results: although the product was not returned, a picture of the insert was provided.The picture was reviewed but no significant observation relating to the current investigation could be derived from it.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: the event could not be confirmed nor the root cause determined as the device was not returned for evaluation.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Scorpio knee surgery: insert tibial 7x12mm ps: when trying to place it and hit it; insert not entered to the tibial tray.Wire was outside of its original position, and not allowed to "fall" in the tibial tray so we had to put another insert less thick.
Additional Manufacturer Narrative
The device was returned for evaluation.An event regarding size/fit issue involving a scorpio insert was reported.The event was confirmed.Device evaluation and results: a visual inspection of the returned device noted that the wire is slightly out of its original place.A review of the returned product with a material analysis engineer indicated "deformation observed anterior surface of insert, likely allowing the wire to separate from the insert." medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: a visual inspection of the returned device noted that the wire is slightly out of its original place.Further review of the returned product with a material analysis engineer indicated that deformation was observed on the anterior surface of insert, likely allowing the wire to separate from the insert.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Scorpio knee surgery: insert tibial 7x12mm ps.When trying to place it and hit it; insert not entered to the tibial tray.Wire was outside of its original position, and not allowed to "fall" in the tibial tray so we had to put another insert less thick.Update: opened the implant when trying to place it in the tibial plate did not enter, so check it and note that the wire is slightly out, derived from this open another insert and place it without biggest problem.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #7 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6573464
• Report Number: 0002249697-2017-01576
• Device Sequence Number: 11046314
• Product Code: JWH
• UDI-Device Identifier: 07613327031041
• UDI-Public: (01)07613327031041(11)151007(17)211031(10)6M6KL4
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 82-7-0712
• Device Catalogue Number: 82-7-0712
• Device Lot Number: 6M6KL4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 06/16/2017; 09/27/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 07/14/2017; 09/27/2017
• 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: Other