MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Scratched Material (3020)

Patient Problems Hematoma (1884); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Foreign Body In Patient (2687); Swelling/ Edema (4577)

Event Date 04/25/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial knee surgery.Subsequently, approximately 5 years later, the surgeon had taken the patient to do a wound debridement due to swelling and pain of right knee post replacement.While the wound was open, the surgeon observed abnormalities of the articular surface and he removed the implant and inserted a new articular surface.The poly appeared to have fine scratches.Infection was also noted to be present.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: unknown - unknown tibial component - unknown.Unknown - unknown femoral component - unknown.G2 : foreign country : south africa.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and 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.Visual examination of the returned product identified signs of wear with nicks, gouges, and pits.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: cement debris was lodged between the iliotibial band in initial surgery, pain and swelling, hemarthrosis, limited rom, abnormalities of the articular surface, ossific densities are noted laterally within the joint space, in the region of the iliotibial band, mild osteopenia, no signs of loosening, wear, radiolucency, or malalignment.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; b6; b7; d2; d10; e1; g1; g3; g6; h1; h2; h6.D10: unknown - unknown cement - unknown product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was further reported that the patient underwent an initial right total knee arthroplasty.Approximately 6 weeks post-op, the patient presented to the office with pain and swelling.A knee aspiration was done with negative results and improvement on range of motion.Approximately 6 weeks later, the patient had a debridement of hemarthrosis, soft tissue, and cement debris with negative cultures.Subsequently, 3 months later, the patient underwent a second incision and drainage procedure due to no improvement in symptoms.During the procedure, the surgeon noted abnormalities to the articular surface.The articular surface was exchanged without complications.Attempts have been made and all available information has been provided.

• Brand Name: ARTICULAR SURFACE FIXED BEARING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16975913
• MDR Text Key: 315743976
• Report Number: 3007963827-2023-00131
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024244788
• UDI-Public: (01)00889024244788(17)230831(10)64125969
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K123459
• 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,Followup,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42522601010
• Device Lot Number: 64125969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2018
• 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.; SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 90 KG