MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMP #2L-CEM; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	5515F201
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Implanted.
Event or Problem Description
It was reported that when right tka surgery, the surgeon incorrectly implanted the left femoral implant.This event was confirmed xp after surgery.It is not scheduled to replace at this time.
Event or Problem Description
It was reported that when right tka surgery, the surgeon incorrectly implanted the left femoral implant.This event was confirmed xp after surgery.It is not scheduled to replace at this time.
Additional Manufacturer Narrative
An event regarding incorrect selection involving a triathlon femoral component was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: not performed as no product was returned for evaluation.It remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: x-ray printouts related to this case include an undated ap and lateral of the right knee demonstrating advanced osteoarthritic changes of the right knee.Another undated ap of both knees and a lateral of the right knee demonstrates bilateral cemented total knee arthroplasties.Both have drains in situ.The left has the components in nominal position, but on the ap film the right demonstrates the left femoral component mistakenly placed.The lateral appears nominal.No clinical or past medical history, no operative report, no patient demographics and no post-operative follow-up is available for review.There is no indication that factors associated with component design, manufacturing or labeling were responsible for this clinical situation.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: based on the provided information the surgeon implanted a left femoral component into the patients right knee.A review of the provided medical records by a clinical consultant indicated: x-ray printouts related to this case include an undated ap and lateral of the right knee demonstrating advanced osteoarthritic changes of the right knee.Another undated ap of both knees and a lateral of the right knee demonstrates bilateral cemented total knee arthroplasties.Both have drains in situ.The left has the components in nominal position, but on the ap film the right demonstrates the left femoral component mistakenly placed.The lateral appears nominal.No adverse consequences were reported and no revision surgery has occurred.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS FEM COMP #2L-CEM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7887366
• Report Number: 0002249697-2018-02947
• Device Sequence Number: 1909099
• Product Code: JWH
• UDI-Device Identifier: 07613327040708
• UDI-Public: 07613327040708
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 5515F201
• Device Lot Number: C299T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 11/19/2018
• 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