MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 20MM MD/LG M2/L2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813320
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar 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
The following was reported: during implantation of final mrh tibial insert, the insert failed to lock to the tibial baseplate anteriorly.After repeated attempts to seat the insert, the decision was made to insert the next larger implant [(b)(4)].This implant seated properly.It was further reported that extra time added to case was 15 minutes and no patient harm occurred.
Additional Manufacturer Narrative
An event regarding a seating/locking issue involving a mrh insert was reported.The event was confirmed by visual inspection.Method & results: -device evaluation and results: implantation damage was observed on the anterior aspect of the insert articulating surface, no material or manufacturing defects were observed on the surfaces examined.-medical records received and evaluation: not performed as no medical records were returned for review.-device history review: indicates 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 lot referenced.Conclusion: based on the visual inspection of the returned product, the observed damage on the anterior surface of the insert is consistent with attempted seating of the insert onto the baseplate.No further investigation for this event is required at this time.
Event or Problem Description
The following was reported: during implantation of final mrh tibial insert, the insert failed to lock to the tibial baseplate anteriorly.After repeated attempts to seat the insert, the decision was made to insert the next larger implant [6481-3-324].This implant seated properly.It was further reported that extra time added to case was 15 minutes and no patient harm occurred.

• Brand Name: MRHK TIB INS 20MM MD/LG M2/L2
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8707619
• Report Number: 0002249697-2019-02287
• Device Sequence Number: 14020349
• Product Code: KRO
• UDI-Device Identifier: 07613327043860
• UDI-Public: 07613327043860
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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: 12/31/2021
• Device Catalogue Number: 64813320
• Device Lot Number: LFL620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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