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

Model Number 400-140F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 08/03/2021

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

It was reported the patient came into clinic with painful total ankle.Surgeon discovered a bone bridge in the medial gutter.Surgeon decided to do a poly swap while he as doing the gutter debridement.No obvious wear on poly, no failures of implants.

Manufacturer Narrative

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 such as x-rays as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the complaint detail, the poly exchange was only made as a precautionary measure since the patient was already revised for gutter debridement.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 more information is provided, the case will be reassessed.

Event Description

It was reported the patient came into clinic with painful total ankle.Surgeon discovered a bone bridge in the medial gutter.Surgeon decided to do a poly swap while he as doing the gutter debridement.No obvious wear on poly, no failures of implants.

• 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: 12474992
• MDR Text Key: 271493199
• Report Number: 0008031020-2021-00413
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400-140F
• Device Catalogue Number: 400140F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 12/02/2021
• 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