MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS POLY LOCK PIN; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060)

Event Date 10/30/2023

Event Type  Injury  

Event Description

It was reported that patient underwent a right knee procedure.Subsequently, patient reported pain and it was believed there was an issue with the femoral.The patient was revised approximately five months post-implantation and during the revision significant arthrofibrosis was noted.However, no issues were noted with the femoral.The bearing and other articulating implants were removed and replaced.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4) multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02734, 0001825034-2023-02735, 0001825034-2023-02737, 0001825034-2023-02738, and 0001825034-2023-02739.D10 medical devices: oss reinforced yoke catalog#: 150493 lot#: 510170 oss axle catalog#: 150480 lot#: 607790 oss poly tibial bushing catalog#: 150476 lot#: 500810 oss tibial poly bearing 12mm catalog#: 150410 lot#: 65676013 oss poly femoral bushings catalog#: 150477 lot#: 236830 unknown oss femoral stem catalog#: ni lot#: ni unknown oss femoral catalog#: ni lot#: ni unknown oss tibial tray catalog#: ni lot#: ni unknown oss tibial stem catalog#: ni lot#: ni g2 foreign source: new zealand customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h10.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.

Event Description

No further event information available at the time of this report.

• Brand Name: OSS POLY LOCK PIN
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18185060
• MDR Text Key: 328702618
• Report Number: 0001825034-2023-02736
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00887868343933
• UDI-Public: (01)00887868343933(17)271006(10)432220
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K052685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150478
• Device Lot Number: 432220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female