MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PROPHECY INFINITY PATIENT SPECIFIC GUIDES; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	PROPINF
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Inaccurate Information (4051)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a "right ankle prosthesis" was ordered for a patient, accompanied by a disc labeled "right ankle." however, a left ankle prosthesis was mistakenly manufactured and delivered.During the right ankle surgery on (b)(6) 2023, the surgeon encountered issues with the cutting jig, which did not fit properly.Upon reviewing the preoperative template, it was discovered that it had been based on a left ankle ct scan.Although the ct scan had been ordered, labeled, and read as a right ankle scan, the images were actually of the left ankle.The procedure was aborted due to the lack of appropriate instrumentation.
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported that a "right ankle prosthesis" was ordered for a patient, accompanied by a disc labeled "right ankle." however, a left ankle prosthesis was mistakenly manufactured and delivered.During the right ankle surgery on (b)(6) 2023, the surgeon encountered issues with the cutting jig, which did not fit properly.Upon reviewing the preoperative template, it was discovered that it had been based on a left ankle ct scan.Although the ct scan had been ordered, labeled, and read as a right ankle scan, the images were actually of the left ankle.The procedure was aborted due to the lack of appropriate instrumentation.
Additional Manufacturer Narrative
Correction to h6 (method code), h6(results code), and h6(conclusion code).The reported event could be confirmed based on the received information and an investigation preformed by the prophecy team.During the investigation, it was determined that left side ct scans were uploaded and used for planning and manufacturing the guides, although the case was created in the system for the right side.A leg side verification email was conducted and the use of the left side scans was confirmed.Additionally, the prophecy case report, which indicated the use of left side ct scans was approved within the system by the surgeon.This sequence of events ultimately resulted in manufacturing of the guides for the incorrect leg side.A nonconformance was initiated to further address the issue.

• Brand Name: PROPHECY INFINITY PATIENT SPECIFIC GUIDES
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20375698
• Report Number: 3010667733-2024-00677
• Device Sequence Number: 20550082
• Product Code: HSN
• UDI-Device Identifier: 00889797057134
• UDI-Public: (01)00889797057134(11)230714(17)240114(10)1765488
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: Health Professional
• Device Expiration Date: 01/14/2024
• Device Catalogue Number: PROPINF
• Device Lot Number: 1765488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male