MAUDE Adverse Event Report: STRYKER GMBH TALAR COMP,SINGLE COATED US VERS MEDIUM, RIGHT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400256

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Implant Pain (4561)

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

A patient reported via medwatch mw5102110 that they had a star ankle replacement in 2013.Pain had steadily increased over the last six months.The doctor had to perform a polyethylene replacement (b)(6) 2021.The original insert was potentially broken.

Event Description

A patient reported via medwatch mw5102110 that they had a star ankle replacement in 2013.Pain had steadily increased over the last six months.The doctor had to perform a polyethylene replacement (b)(6), 2021.The original insert was potentially broken.

Manufacturer Narrative

H6 clinical code corrected.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the (correct) lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TALAR COMP,SINGLE COATED US VERS MEDIUM, RIGHT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12318759
• MDR Text Key: 266409364
• Report Number: 0008031020-2021-00362
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: 1004220468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2021
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 82 KG