MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP TIB KEELED NONPOR SIZE 2+ LEFT; KNEE COMPONENT

Model Number	ETPKN2PL
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, during the operation, the doctor opened the box of product " etpkn2pl, lot-1916559", but actually the product inside the box is "etpkn7sl, lot-1916715".Once being aware of the incident, the doctor switched to another product (etpkn2pl, lot.1928701) immediately.The operation was completed finally.Additional information received on 10/27/2022: this incident delayed the surgery by 30 minutes.Domestic ae report number reference: (b)(4).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: EVOLUTION®MP TIB KEELED NONPOR SIZE 2+ LEFT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 15743440
• Report Number: 3010536692-2022-00377
• Device Sequence Number: 20608471
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN2PL1
• UDI-Public: M684ETPKN2PL1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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: Other
• Device Model Number: ETPKN2PL
• Device Catalogue Number: ETPKN2PL
• Device Lot Number: 1916559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0275-2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown