MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #1 RM/LL -9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5630-G-129
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicates products were manufactured and accepted into final stock with no 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, right pka.It was reported that the insert would not seat into the baseplate.A 2nd implant was available, used, and performed as expected.Rep reported a 15-20 minute surgical delay with use of tourniquet.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.
Additional Manufacturer Narrative
An event regarding seating/locking issue involving a triathlon insert was reported.The event was confirmed by visual inspection of the returned product.Review of the returned product by a material analysis engineer indicated that damage observed on insert consistent with attempted implantation and explantation of device.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: not performed as no medical records were provided for review.Indicate all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar reported events for the lot referenced.Review of device by a material analysis engineer indicated that damage observed on insert consistent with attempted implantation and explantation of device.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is required at this time.
Event or Problem Description
Primary procedure, right pka.It was reported that the insert would not seat into the baseplate.A 2nd implant was available, used, and performed as expected.Rep reported a 15-20 minute surgical delay with use of tourniquet.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: TRIATHLON PKR INSERT X3 #1 RM/LL -9MM
• 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: 7532649
• Report Number: 0002249697-2018-01504
• Device Sequence Number: 1121862
• Product Code: HRY
• UDI-Device Identifier: 07613327015836
• UDI-Public: 07613327015836
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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: 12/21/2021
• Device Catalogue Number: 5630-G-129
• Device Lot Number: 838AV6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 08/03/2018
• 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: 60 YR
• Patient Weight: 98