MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 5 LEFT 1; KNEE COMPONENT

Model Number	KIMP510L
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.This patient was stated to have been revised due to stiffness approximately 50 months after the primary operation.The revised products were not returned for investigation.No radiographs or operative notes are available to evaluate component positioning.Review of the device history record for this lot indicates that this product met all acceptance criteria at the time of manufacturing.The current knee systems package insert (150806-2) lists "inadequate range of motion due to improper selection or positioning of components, periarticular calcification, flexion contracture" as a possible adverse effect of total knee arthroplasty.There were no trends identified per mpo trending procedures.No further conclusions can be drawn from the available information.This issue will continue to be monitored through complaint tracking.
Event or Problem Description
Allegedly, patient was revised due to stiffness.Revision njr number: (b)(4).Side: l; primary asa: p2 - mild disease not incapacitating.

• Brand Name: ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 5 LEFT 1
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 12132679
• Report Number: 3010536692-2021-00365
• Device Sequence Number: 17334737
• Product Code: JWH
• UDI-Device Identifier: M684KIMP510L1
• UDI-Public: M684KIMP510L1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K972770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: Health Professional
• Device Model Number: KIMP510L
• Device Catalogue Number: KIMP510L
• Device Lot Number: 1688969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention