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

Model Number	400-142F
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11645428
• Report Number: 0008031020-2021-00145
• Device Sequence Number: 3049889
• Product Code: NTG
• UDI-Device Identifier: 00886385026947
• UDI-Public: 00886385026947
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 400-142F
• Device Catalogue Number: 400142F
• Device Lot Number: 1543203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR