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

Catalog Number 400256

Device Problems Break (1069); Unstable (1667)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/09/2015

Event Type  Injury  

Manufacturer Narrative

The reported device was manufactured and distributed by (b)(4) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of (b)(4) on (b)(6) 2014.Stryker became legal manufacturer of this product on april 1, 2015 and has taken the responsibility for medical device reporting.Unknown star talar component device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device will not be returned for evaluation.

Event Description

Converting star to an in-bone on (b)(6) 2015.Surgeons progress notes indicated that the patient came in for reevaluation of her ankle.She states that she had been doing well until recently.Her x rays show that her fibula is fractured.I think the tibial component is probably unstable.Her screw is broken in the lateral malleolus.We are going to need to revise this just based on the talar side.I think i will need to use an in-bone based on the tibial side.I,i'm going to need to revise her to an in-bone.

Manufacturer Narrative

Evaluation revealed the tibial comp, single coated us version, large, the revision sliding core 14 mm and the talar comp, single coated us vers medium, right to be the subject products.No further associated products were reported.Deficiency in material or manufacturing was not found.The affected items were documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.The explanted polyethylene sliding core and both metal components showed normal traces of use (like slight scratches), but no signs of abrasion, damage or breakage.Progress notes from the follow up examination from september 01, 2015 stated that the fibula of the patient is fractured.Furthermore it indicated that ¿the tibial component is probably unstable¿ and that ¿her screw is broken in the lateral malleolus¿.Reasons for bone breakage can be various (e.G.But not limited to: week bones, fall, etc.).In this case the surgeon gave no further indication what may have caused the fracture of the fibula resulting in a potential instability of the tibial component.The attending physician decided to revise the patient.The star ankle implants were removed and replaced by in-bone.The reported information did not allege any deficiency in the identity, quality, reliability, safety, effectiveness or performance of the device.Potential device loosening was considered in the risk analysis.The risk of bone fracture is pointed out in the ifu.Based on the above information and referring to that no deviation was found during investigation, the event was not linked to a deficiency of the devices, but was rather patient related.In case relevant information becomes available we reserve the right to update the investigation and to change the root cause.

Event Description

Converting star to an in-bone on (b)(6) 2015.Surgeons progress notes indicated that the patient came in for reevaluation of her ankle.She states that she had been doing well until recently.Her x rays show that her fibula is fractured.I think the tibial component is probably unstable.Her screw is broken in the lateral malleolus.We are going to need to revise this just based on the talar side.I think i will need to use an in-bone based on the tibial side.I'm going to need to revise her to an in-bone.

• Brand Name: TALAR COMP,SINGLE COATED US VERS MEDIUM, 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: 5117455
• MDR Text Key: 27239614
• Report Number: 0008031020-2015-00398
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 400256
• Device Lot Number: 110698/403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/1999
• 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