MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #3 LM/RL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5630-G-308
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
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.Device not returned.
Event or Problem Description
Primary procedure, manual left medial pkr.It was reported that the poly would not go in correctly to the baseplate using the tibial impactor (catalog 5650-4-812).Another device of the same catalog but different lot was obtained and performed correctly.Surgery was completed successfully with a delay of approximately 1 minute while a tourniquet was being used.
Additional Manufacturer Narrative
An event regarding seating/locking 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 that dent marks and damages are observed on the surface of the device.Examination of the returned device by a material analysis engineer noted that implantation/explantation damage was observed on the rim of the insert, no materials or manufacturing defects were observed on the surfaces examined.Dimensional and functional analysis were not performed as the device was returned in damaged condition.- clinician review: no medical records were received for review with a clinical consultant.- device history review: all 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 reported lot.Conclusion: it was reported that the poly would not go in correctly to the baseplate using the tibial impactor.Visual inspection of the returned device noted that dent marks and damages are observed on the surface of the device.Examination of the returned device by a material analysis engineer noted that implantation/explantation damage was observed on the rim of the insert, no materials or manufacturing defects were observed on the surfaces examined.The event was not confirmed and the exact cause of the event could not be determined because insufficient information was provided.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, manual left medial pkr.It was reported that the poly would not go in correctly to the baseplate using the tibial impactor (catalog 5650-4-812).Another device of the same catalog but different lot was obtained and performed correctly.Surgery was completed successfully with a delay of approximately 1 minute while a tourniquet was being used.

• Brand Name: TRIATHLON PKR INSERT X3 #3 LM/RL -8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8703425
• Report Number: 0002249697-2019-02264
• Device Sequence Number: 1992275
• Product Code: HRY
• UDI-Device Identifier: 07613327015928
• UDI-Public: 07613327015928
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082567
• 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): 07/26/2019

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: 11/30/2023
• Device Catalogue Number: 5630-G-308
• Device Lot Number: DD0D41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/26/2019
• 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: 74 YR