MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #7; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5520-B-700
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
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
As reported: "baseplate wouldn't fully engage onto the baseplate inserter." spoke to rep, who was present for the procedure.Primary tka.A second baseplate was opened and engaged onto the same inserter without issue.Surgery was completed successfully with a delay of approximately 1 minute while a tourniquet was in use.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding seating/locking issues involving a triathlon baseplate was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: the device was returned for evaluation.Damage consistent with implantation attempt.Dimensional inspection was performed.The device failed the inspection at island width.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the 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.Conclusions: it was reported that the device wouldn't fully engage onto the baseplate inserter.Evaluation of the returned device noticed that the device failed the dimensional inspection at island width.The reported event is deemed to be caused due to a manufacturing issue.An nc was issued for triathlon baseplate assembly issue / dimension out of specifications.Lot specific recall - pfa 2686166 was issued on the 1st of july.
Event or Problem Description
As reported: "baseplate wouldn't fully engage onto the baseplate inserter." spoke to rep, who was present for the procedure.Primary tka.A second baseplate was opened and engaged onto the same inserter without issue.Surgery was completed successfully with a delay of approximately 1 minute while a tourniquet was in use.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #7
• 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: 10990220
• Report Number: 0002249697-2020-02642
• Device Sequence Number: 16300908
• Product Code: MBH
• UDI-Device Identifier: 07613327041064
• UDI-Public: 07613327041064
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/01/2021

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: 11/30/2024
• Device Model Number: 5520-B-700
• Device Catalogue Number: 5520B700
• Device Lot Number: JHS2H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 06/26/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 07/01/2021
• 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 2686166
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other