MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE, UHMPWE,6M (STERILE PACKAGED); PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Model Number 400-140F

Device Problems Break (1069); Fracture (1260)

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

Event Date 01/22/2021

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 revision surgery was reported to stryker - reason for revision "fractured poly pain"."fractured 6mm poly replaced with a 7mm without difficulty" "no abnormalities, no concerns with the surgical site".

Event Description

A revision surgery was reported to stryker - reason for revision "fractured poly pain"."fractured 6mm poly replaced with a 7mm without difficulty" "no abnormalities, no concerns with the surgical site".

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.The case is about an 80yo female patient with a bmi of 27.6 that was implanted with a star poly in 2016, which broke and provoked pain in 2021 (5 years of implantation).More detailed information about the complaint event such as x-rays, 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 for the reported lot did not indicate any abnormalities.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: SLIDING CORE, UHMPWE,6M (STERILE PACKAGED)
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12785790
• MDR Text Key: 280573399
• Report Number: 0008031020-2021-00451
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385026923
• UDI-Public: 00886385026923
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 400-140F
• Device Catalogue Number: 400140F
• Device Lot Number: 1450195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2015
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 77 KG