MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE GH 12 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Swelling/ Edema (4577)

Event Date 11/12/2019

Event Type  Injury  

Event Description

It was reported the patient underwent a left knee revision approximately seven years post-implantation due to pain and instability.During the revision there was noted synovitis, inflammation of soft tissue, cyst, scarring, and fibrosis.The tibia, articular surface, and femur were exchanged with competitor products.The patella remained implanted.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00208 and 0002648920-2022-00173.Concomitant medical devices: femoral component option size g left catalog#: 00599601751 lot#: 62148266, stemmed nonaugmentable tibial component option cr/ps/lps size 5 catalog#: 00598604701 lot#: 62133493, all poly patella standard cemented size 38 mm diameter 9.5 mm thickness catalog#: 00597909551 lot#: 62084495.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.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.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: osteolysis found, femoral and tibial implants were loose, synovitis was found, soft tissue was inflamed, and cysts were found in both the tibial and femoral areas, there was scarring and fibrosis, and instability was found.Range of motion was noted to be normal.Radiographs were also provided and reviewed by a health care professional.Review of the available records identified the following: overall fit and alignment of the implant is appropriate.Osteopenia is present.There is possible loosening of the tibial and femoral components and also possible osteolysis at the tip of the tibial stem.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.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARTICULAR SURFACE SIZE GH 12 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15209049
• MDR Text Key: 297684212
• Report Number: 0001822565-2022-02349
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00596404212
• Device Lot Number: 62055623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2012
• 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 Sex: Male
• Patient Weight: 113 KG