MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 16MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813216
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: "surgeon was explanting non-stryker tka implants subsequent to a periprosthetic fracture and reconstructing with a distal femoral gmrs construct.All implants were assembled on the back table prior to implantation.Surgeon felt that mrh tibial insert did not adequately engage/ lock into mrh baseplate.Another insert was provided.".
Additional Manufacturer Narrative
An event regarding a seating/locking issue involving a mrh insert was reported.The event was confirmed by visual inspection.One mrh insert with the lot code lfr522 was returned for evaluation.No packaging was returned with the device.Multi directional scratches are visible on the inferior surface of the device, there is also a scratch visible on the superior surface of the device.Damage consistent with attempted implantation of the device is visible on the anterior surface of the insert.Medical records received and evaluation: not performed as no medical records were returned for review.Indicates all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
As reported: "surgeon was explanting non-stryker tka implants subsequent to a periprosthetic fracture and reconstructing with a distal femoral gmrs construct.All implants were assembled on the back table prior to implantation.Surgeon felt that mrh tibial insert did not adequately engage/lock into mrh baseplate.Another insert was provided.".

• Brand Name: MRHK TIB INS 16MM XS/S S1/S2
• 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: 7292644
• Report Number: 0002249697-2018-00535
• Device Sequence Number: 135189
• Product Code: KRO
• UDI-Device Identifier: 07613327043808
• UDI-Public: 07613327043808
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): 05/02/2018

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: 03/31/2022
• Device Catalogue Number: 64813216
• Device Lot Number: LFR522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Initial Date Received by Manufacturer: 01/27/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 05/02/2018
• 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
• Patient Age: 88 YR
• Patient Weight: 71