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

Catalog Number 400252

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device not returned.

Event Description

A star implant was put in (b)(6).I received a text with a photo from the doctor the following day saying "is that tilted to posterior" "ask your people".I sent the photo to the specialist and got the surgeon enrolled in the surgeon guidance program immediately to answer his question.No further information was provided until today when i found out a revision was done to reposition the tatar component.Nothing was wrong with the implant itself.Doctor text concern post op if the tatar component was to posterior.A revision was completed to correct the posterior position of the tatar component.

Manufacturer Narrative

Evaluation revealed the talar component to be the primary product.The other implants reported are considered associated products.The reported devices were not returned for evaluation; according to the sales rep the talar component was not explanted but was just repositioned.The sales rep further reported that to his knowledge the tibial component was not explanted, as well.He stated that nothing was wrong with the implant itself and that the surgeon had concerns post (primary) surgery whether the talar component was too posterior.The repositioning of the talar component was carried out by another surgeon.Since no product malfunction was reported and the subject implant stayed in place a review of the device history records for the talar component as well as review of the complaint history and capa databases was deemed not necessary.Based on the information given no non-conformity was identified.

Event Description

A star implant was put in (b)(6) 2018.I received a text with a photo from the doctor the following day saying "is that tilted to posterior" "ask your people".I sent the photo to the specialist and got the surgeon enrolled in the surgeon guidance program immediately to answer his question.No further information was provided until today when i found out a revision was done to reposition the tatar component.Nothing was wrong with the implant itself.Doctor text concern post op if the tatar component was to posterior.A revision was completed to correct the posterior position of the tatar component.

• Brand Name: TALAR COMP,SINGLE COATED US VERS X-SMALL, RIGHT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6645552
• MDR Text Key: 77700510
• Report Number: 0008031020-2017-00358
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 400252
• Device Lot Number: 1507123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: 10/06/2017
• Supplement Dates FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 160