MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5532-G-313
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
When triathlon ps x3 tibial insert (13mm) was attempted to fix using an impactor, inside was fixed without a gap.But there was about 1mm gap outside and it could not be fixed.The base plate was then cleaned completely and attempted to fix the insert again.But the status was the same.The insert was then exchanged with 11mm one.The reporter¿s request: please investigate and confirm if the insert (13mm) can be actually fixed to a tibial base plate.Alternate translation december 5, 2019: x3 insert ps13mm was used.I inserted it with an impactor but the inside was fixed without a gap.The outside floated about 1mm and could not be fixed.After thoroughly cleaning the baseplate and trying again, the same phenomenon occurred and an 11mm insert was inserted.Is there a defect in the insert itself? if not, what can be the reason for this?.
Event or Problem Description
When triathlon ps x3 tibial insert (13mm) was attempted to fix using an impactor, inside was fixed without a gap.But there was about 1mm gap outside and it could not be fixed.The base plate was then cleaned completely and attempted to fix the insert again.But the status was the same.The insert was then exchanged with 11mm one.The reporter¿s request: please investigate and confirm if the insert (13mm) can be actually fixed to a tibial base plate.Alternate translation december 5, 2019: x3 insert ps13mm was used.I inserted it with an impactor but the inside was fixed without a gap.The outside floated about 1mm and could not be fixed.After thoroughly cleaning the baseplate and trying again, the same phenomenon occurred and an 11mm insert was inserted.Is there a defect in the insert itself? if not, what can be the reason for this?.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: damage consistent with the explantation process was observed on the anterior surface of the implant.Damage consistent with attempted implantation was observed on the articulating and posterior surfaces of the implant.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional and functional testing were not possible due to the damage noted on the returned product.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: no photograph was provided of the intra-operative event where it was reported there was a gap between the insert and baseplate components.Visual inspection of the returned device noted the following: damage consistent with the explantation process was observed on the anterior surface of the implant.Damage consistent with attempted implantation was observed on the articulating and posterior surfaces of the implant.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.It is was reported that the insert was removed and a second implantation was attempted without success.Following this an 11mm insert was used and implanted without issue.The exact cause of the event could not be determined, it is not known if any intra-operative event took place which may have resulted in the seating/locking issue.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 9521852
• Report Number: 0002249697-2019-04123
• Device Sequence Number: 16219885
• Product Code: MBH
• UDI-Device Identifier: 07613327050653
• UDI-Public: 07613327050653
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• 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): 02/25/2020

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: 10/31/2023
• Device Model Number: 5532-G-313
• Device Catalogue Number: 5532-G-313
• Device Lot Number: 99042818C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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