MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5536-B-400
Medical Device Problem Codes	Defective Component (2292); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
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.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 knee.The following sequence of events were reported: a 4x11 cs insert would not lock on the baseplate.Surgeon removed the insert, inspected the baseplate to ensure no soft tissue was impinging, and used a second 4x11 cs insert, which also would not lock.The insert was removed, the site was triple-checked to ensure there was no soft tissue impingement, and a third 4x11 cs insert was used.The surgeon felt the insert was sitting.5mm to 1mm proud.A new baseplate was opened and a 4x9 insert was locked into it as there was only one 4x11 cs insert left in the hospital.This construct was used to visually compare the in-situ baseplate and insert and the 4x11 was deemed to be proud.The 4x11 insert and baseplate in situ were removed, the 4x9 insert (which was never in contact with the patient) was separated from the baseplate and disposed.The new baseplate was implanted, and the fourth 4x11 cs insert locked into the baseplate.Surgery was completed successfully with a delay of approximately 30 minutes with use of tourniquet.The surgeon (who is a (b)(6) consultant) wants the wasted baseplate and 4x11 cs inserts investigated, and he wants the results.Rep, who was present for and witnessed the event, provided the usage sheet and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding assembly issue involving a triathlon baseplate was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: the baseplate and four inserts were returned for evaluation.There are scratch marks on the devices which indicated that they were attempt to be implanted.Nothing else remarkable to report.Dimensional inspection of the returned device revealed that the device island profile feature oversized by 0.031mm.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: dimensional inspection of the returned device revealed that the device island profile feature oversized by 0.031mm, which is determined to be a manufacturing issue.An nc was issued for triathlon tritanium baseplate - island width out of specification.Lot specific recall - pfa 2519880 was issued on the 10th of february.
Event or Problem Description
Primary procedure, left knee.The following sequence of events were reported: a 4x11 cs insert would not lock on the baseplate.Surgeon removed the insert, inspected the baseplate to ensure no soft tissue was impinging, and used a second 4x11 cs insert, which also would not lock.The insert was removed, the site was triple-checked to ensure there was no soft tissue impingement, and a third 4x11 cs insert was used.The surgeon felt the insert was sitting.5mm to 1mm proud.A new baseplate was opened and a 4x9 insert was locked into it as there was only one 4x11 cs insert left in the hospital.This construct was used to visually compare the in-situ baseplate and insert and the 4x11 was deemed to be proud.The 4x11 insert and baseplate in situ were removed, the 4x9 insert (which was never in contact with the patient) was separated from the baseplate and disposed.The new baseplate was implanted, and the fourth 4x11 cs insert locked into the baseplate.Surgery was completed successfully with a delay of approximately 30 minutes with use of tourniquet.The surgeon (who is a mako consultant) wants the wasted baseplate and 4x11 cs inserts investigated, and he wants the results.Rep, who was present for and witnessed the event, provided the usage sheet and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRITANIUM BPLATE TRIATHLON S4
• 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: 10566220
• Report Number: 0002249697-2020-01956
• Device Sequence Number: 19500888
• Product Code: MBH
• UDI-Device Identifier: 07613327041491
• UDI-Public: 07613327041491
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: 05/31/2020
• Device Model Number: 5536-B-400
• Device Catalogue Number: 5536B400
• Device Lot Number: CTD44301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: PFA 2519880
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR