MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Osteolysis (2377); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Associated products : item#:42502606202;femur cemented (cr) standard right size 7;lot#:63580961.Item#:42521000418;articular surface fixed (cr) right 18 mm height; lot#:63309926.Item#:42540000032;all poly patella cemented 32 mm diameter; lot#:63950024.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Initial right unicondylar knee arthroplasty performed on an unknown date with unknown product.The patient was subsequently converted to a total knee on approximately 2 years ago due to femoral loosening and avascular necrosis.The patient was again revised to a rotating hinge knee due to tibial loosening.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays.Device history record (dhr) was reviewed and no discrepancies were found.X-rays were provided and reviewed by a health care professional.Review found abnormal radiolucency reflecting osteolysis surrounding the tibial implant and the tibial stem is angulated laterally with apparent medial tibial tray subsidence.There is resulting marked varus alignment of the knee.Tibial implant is loose.A small focus of lucency is present within the lateral femoral condyle.Femoral implant fit is maintained.Bone quality is osteopenic.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.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10609837
• MDR Text Key: 209346304
• Report Number: 0002648920-2020-00438
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024471047
• UDI-Public: (01)00889024471047
• Combination Product (y/n): N
• PMA/PMN Number: K122765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532006702
• Device Lot Number: 62881710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention