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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2019

Event Type  malfunction  

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 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.

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 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
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8707619
• MDR Text Key: 148302583
• Report Number: 0002249697-2019-02287
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327043860
• UDI-Public: 07613327043860
• Combination Product (y/n): N
• PMA/PMN Number: K994207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other