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

Catalog Number 400254

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.(b)(4).Product inquiry stated the tibial comp, single coated us version, small, the sliding core (b)(4), 7mm and the talar comp,single coated us version small, right to be the subject products.No further associated products were reported.The affected items were documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.A physical examination could not be carried out as the devices were not available for evaluation.Thus, a reasonable examination and investigation was not possible.At this time, it cannot be determined which if any of the devices in this event may have caused or contributed to the patients' experience therefore, the product information will be referenced.Additional devices listed in this report: catalog # 400261; tibial comp, single coated us version, small lot# 051191 / 212.Catalog # 400141; talar comp, single coated us version small, right lot# 010905 / 2029.Device remains implanted.

Event Description

Radiolucency 5mm was observed on inferior/ medial to talar component.No treatment was prescribed.

• Brand Name: TALAR COMP,SINGLE COATED US VERSION 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5606310
• MDR Text Key: 44222387
• Report Number: 0008031020-2016-00212
• 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: Other
• Type of Report: Initial
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2007
• Device Catalogue Number: 400254
• Device Lot Number: 010905-2029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2002
• 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): Other
• Patient Age: 76 YR
• Patient Weight: 57