MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STAR POLY MOBILE BEARING; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number UNK_SEL

Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Swelling (2091)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Mobile bearing was fractured.Doctor's visit note from (b)(6) 2019 states: "she is here today for reevaluation of her left (star) ankle.She states that she is having increased pain.She has been getting along well until recently.She states that her pain is to the point she is walking in a cam walker and using a cane.On exam she has moderate swelling.She has instability of her ankle as well.X-rays show some abnormality of her ankle joint that make me think she may have fractured her poly".Revision surgery occurred as a result.

• Brand Name: UNKNOWN STAR POLY MOBILE BEARING
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• 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: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8898802
• MDR Text Key: 155547105
• Report Number: 0008031020-2019-01053
• 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: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 74 YR