MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NRG KNEE CR NRG BEARING INSERT SIZE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	82-2-0710
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Insert could not be inserted.The insert was not engraved, catalog# and sn# were missing on the item.To complete the surgery successfully a 12mm insert was used.
Additional Manufacturer Narrative
An event regarding the inability to assemble an insert and a lack of engraving on the component was reported.The assembly issue was not confirmed however it was confirmed that the marking on the device was very feint.Method & results: device evaluation and results: a visual inspection was performed on the returned device.A review of the device identified that the engraved numbers were present although quite faint.A dimensional inspection was not performed as the device was washed at elevated temperature which distorts dimensional aspects of the device.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices 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.Conclusion: the exact cause of the event could not be determined.The device was washed at elevated temperatures which can cause changes to the dimensions of the device and can cause the engravings to deteriorate to a point where they are not visible so it is not possible to confirm if the engravings were visible prior to washing.Additional information including pre washing photo's are needed to fully investigate the event.If further information becomes available , this investigation will be re-opened.
Event or Problem Description
Insert could not be inserted.The insert was not engraved, catalog# and sn# were missing on the item.To complete the surgery successfully a12mm insert was used.

• Brand Name: NRG KNEE CR NRG BEARING INSERT SIZE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8436134
• Report Number: 0002249697-2019-01379
• Device Sequence Number: 2051437
• Product Code: JWH
• UDI-Device Identifier: 04546540400673
• UDI-Public: 04546540400673
• Combination Product (Y/N): N
• PMA/510(K) Number: K042343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: 08/31/2021
• Device Catalogue Number: 82-2-0710
• Device Lot Number: 56895401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 07/04/2019
• 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: Other