MAUDE Adverse Event Report: STRYKER GMBH TALAR COMP,SINGLE COATED US VERS X-SMALL, LEFT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number	400253
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Thrombosis (2100)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
Event or Problem Description
It was reported via an adverse event report (ankle star study) that the subject was admitted to the hospital on (b)(6) 2018, seven days post-op of a star in left ankle on (b)(6) 2018.The subject was diagnosed with bilateral second and third order pulmonary emboli.Ultrasound of right leg showed an infrapopliteal tibial vein thrombus.No thrombi above the knee found in either leg.The left lower leg could not be sounded because of wound dressing.Subject was prescribed with an anticoagulation of eliquis 10mg.Patient was discharged on (b)(6) 2018 and event is continuing with treatment".
Event or Problem Description
It was reported via an adverse event report (ankle star study) that the subject was admitted to the hospital on (b)(6)2018 , seven days post-op of a star in left ankle on (b)(6)2018.The subject was diagnosed with bilateral second and third order pulmonary emboli.Ultrasound of right leg showed an infrapopliteal tibial vein thrombus.No thrombi above the knee found in either leg.The left lower leg could not be sounded because of wound dressing.Subject was prescribed with an anticoagulation of eliquis 10mg.Patient was discharged on (b)(6)2018 and event is continuing with treatment".
Additional Manufacturer Narrative
The reported event was reviewed and evaluated by a hcp to define whether the products did contribute to the event reported.The hcp defined the case as sae; according to procedure dqi 20-030 ¿clinical investigation - adverse event reporting¿ sae means serious adverse event and is not device-related.Therefore a relationship between the bilateral second and third order pulmonary emboli and the star implants can be excluded.Medical expert statement: note that any kind of bone injury, mainly in the lower extremity, bears the risk of venous thrombosis and pulmonary embolism.In many cases there will be a mild thrombosis which is not noticed by the patient or will result in slight swelling of the soft tissue with spontaneous remission.In the case of a manifest extended thrombosis specific medical and clinical measures are required.Only in rare cases a post-thrombotic syndrome with permanent swelling and significant affection of the circulation will result from such an event.As a sequel of a thrombosis there may be a pulmonary embolism.A mild pulmonary embolism may cause cardiopulmonary symptoms with spontaneous remission.In the case of a manifest extended pulmonary embolism specific medical and clinical measures are required.With all of these adverse events, none are related directly to the implant, but rather to the trauma induced by the surgical procedure.Because the reported event is not device related it is not a complaint according to procedure cqm-02 ¿stryker corporation quality and regulatory master glossary¿; according to the procedure a complaint is defined as ¿any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a stryker device after it is released for distribution by a manufacturing site.¿.

• Brand Name: TALAR COMP,SINGLE COATED US VERS X-SMALL, LEFT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7593466
• Report Number: 0008031020-2018-00459
• Device Sequence Number: 2018726
• Product Code: NTG
• UDI-Device Identifier: 00886385016443
• UDI-Public: 00886385016443
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2018

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: Lay User/Patient
• Device Catalogue Number: 400253
• Device Lot Number: 1543234
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/27/2018
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 83