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

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  malfunction  

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 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.

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 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
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7532649
• MDR Text Key: 108856090
• Report Number: 0002249697-2018-01504
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 07613327015836
• UDI-Public: 07613327015836
• Combination Product (y/n): N
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 98