MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-400
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary procedure, left tkr.Rep reported that a box marked for a size 4 tibial baseplate was opened and the device inside implanted.Upon trialing for the insert, size 4 trial would not fit.Upon examination it was discovered the implant was a size 3.The surgeon had considered both size 3 and 4 implants prior to implantation, and reported that the size 3 implant would remain in the patient.Rep confirms he was in the o.R.At the time of opening and implantation.Rep has pictures of the implant and the packaging, and will be returning the packaging.
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts baseplate size 3; cat# 5521-b-300; lot# atv7ia it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding product mix involving a triathlon baseplate was reported.The event was confirmed by photographs and the returned device.Conclusions: the packaging was returned however, images of the device and package label were provided which confirmed that the device was nonconforming.An nc was issued for the product mix and is currently being investigated.Further investigation will be conducted and documented in the nc record.No further investigation is required at this time.
Event or Problem Description
Primary procedure, left tkr.Rep reported that a box marked for a size 4 tibial baseplate was opened and the device inside implanted.Upon trialing for the insert, size 4 trial would not fit.Upon examination it was discovered the implant was a size 3.The surgeon had considered both size 3 and 4 implants prior to implantation, and reported that the size 3 implant would remain in the patient.Rep confirms he was in the o.R.At the time of opening and implantation.Rep has pictures of the implant and the packaging, and will be returning the packaging.

• Brand Name: TRI TS BASEPLATE SIZE 4
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7229452
• Report Number: 0002249697-2018-00278
• Device Sequence Number: 16173667
• Product Code: MBH
• UDI-Device Identifier: 07613327026061
• UDI-Public: 07613327026061
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 12/31/2022
• Device Catalogue Number: 5521-B-400
• Device Lot Number: ATY4OA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 04/04/2018
• 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: 43 YR
• Patient Weight: 104