MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #4 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5620-B-401
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.Device evaluation is anticipated but not yet begun.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary procedure, left stryker partial knee.It was reported that upon opening the box for a size 4 left medial tibial baseplate, the device and implant stickers inside the box were for a 3x8 left medial tibial insert.The surgeon elected to wait for the correct implant to be retrieved, but after 1 hour 15 minutes (both with and without use of tourniquet) decided to cement in a size 3 tibial baseplate.The original 3x8 insert was not used, a 4x8 insert which had been opened (as per original surgical plan) was wasted, and a different 3x8 insert was used to complete the surgery successfully.The outer box, device stickers, and device in its sterile blisters have been retained.
Event or Problem Description
Primary procedure, left stryker partial knee.It was reported that upon opening the box for a size 4 left medial tibial.Baseplate, the device and implant stickers inside the box were for a 3x8 left medial tibial insert.The surgeon elected to wait for the correct implant to be retrieved, but after 1 hour 15 minutes (both with and without use of tourniquet) decided to cement in a size 3 tibial baseplate.The original 3x8 insert was not used, a 4x8 insert which had been opened (as per original surgical plan) was wasted, and a different 3x8 insert was used to complete the surgery successfully.The outer box, device stickers, and device in its sterile blisters have been retained.
Additional Manufacturer Narrative
An event regarding a product swap involving a triathlon baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material evaluation and indicated the following comments: the carton received is labeled with "triathlon pkr tibial baseplate" on the side panel.Catalog number listed is "5620-b-401".Lot number listed is "jszna".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 the product manufacturing cell representative reviewed the event and stated: no indication of quarantine or nonconformances were found to be documented within either dhr for each of the products tied to this complaint manufacturing dates for both devices are over a year apart.This is evidence that this potential product swap was not created from a manufacturing error.Therefore, this complaint does not require escalation to a non conformance.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.

• Brand Name: TRIATHLON PKR BASEPLATE #4 LM/RL
• 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: 8752404
• Report Number: 0002249697-2019-02472
• Device Sequence Number: 11272143
• Product Code: HRY
• UDI-Device Identifier: 07613327015546
• UDI-Public: 07613327015546
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/19/2019

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: 03/31/2021
• Device Catalogue Number: 5620-B-401
• Device Lot Number: JSZNA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: 49 YR