MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE, UHMPWE,8MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Model Number 400-142F

Device Problem Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device was lost or discarded by the customer.

Event Description

The following event was reported:" patient presented at dr.(b)(6).Office with ankle instability.He examined the joint and determined that a new poly was necessary.We performed the revision surgery and swapped the 8mm poly for a 9mm poly.Original dos (b)(6) 2020.

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 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 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.

Event Description

The following event was reported:" patient presented at dr.M.Office with ankle instability.He examined the joint and determined that a new poly was necessary.We performed the revision surgery and swapped the 8mm poly for a 9mm poly.Original dos (b)(6) 2020.

• Brand Name: SLIDING CORE, UHMPWE,8MM
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11645428
• MDR Text Key: 246104421
• Report Number: 0008031020-2021-00145
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385026947
• UDI-Public: 00886385026947
• Combination Product (y/n): N
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400-142F
• Device Catalogue Number: 400142F
• Device Lot Number: 1543203
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR