MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5536-B-600
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a product mix issue, so the device information located on the outer box label is being reported in section d and the information for the device that was actually inside the package is : cat# titanium bplate s5; cat # 5536b500; lot # ctd69106 product field action has been initiated.Investigation ongoing.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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, left mako tka.It was reported that the packaging and labels were for a size 6 press-fit baseplate (catalog and lot).The implant was a size 5 press-fit baseplate (different catalog and lot).Discovery was made when the surgeon attempted to implant a size 6 insert and it wouldn't fit.Hospital staff then called out the catalog and lot on the implant to the rep.Surgeon elected to leave the size 5 baseplate implanted and implanted a fitting insert.Surgery completed successfully with a delay of approximately 5 minutes.Rep reported he can provide pictures of the packaging (but not of the implant as it was in the patient/ sterile field by that time).Rep also confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding product mix involving a triathlon baseplate was reported.The event was confirmed through evaluation of the provided photographs.Method & results: product evaluation and results: the device itself was not returned as it was implanted however photographs of the packaging were provided.The photographs show the unit carton, labels containing the catalog and lot details for a size 6 baseplate are fixed to the unit carton.Writing with black pen on the label states that inside the box was a size 5 baseplate.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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: visual inspection of the returned packaging confirmed the event.Nc was raised to address this event.
Event or Problem Description
Primary procedure, left mako tka.It was reported that the packaging and labels were for a size 6 press-fit baseplate (catalog and lot).The implant was a size 5 press-fit baseplate (different catalog and lot).Discovery was made when the surgeon attempted to implant a size 6 insert and it wouldn't fit.Hospital staff then called out the catalog and lot on the implant to the rep.Surgeon elected to leave the size 5 baseplate implanted and implanted a fitting insert.Surgery completed successfully with a delay of approximately 5 minutes.Rep reported he can provide pictures of the packaging (but not of the implant as it was in the patient/ sterile field by that time).Rep also confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRITANIUM BPLATE TRIATHLON S6
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13937739
• Report Number: 0002249697-2022-00447
• Device Sequence Number: 11881309
• Product Code: MBH
• UDI-Device Identifier: 07613327041514
• UDI-Public: 07613327041514
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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 Model Number: 5536-B-600
• Device Catalogue Number: 5536B600
• Device Lot Number: CTD69463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1237-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Male