MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS CEMENTED IM STEM; PROSTHESIS KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: oss 3cm resurfacing rt catalog#: 151805, lot#: 462860.Oss poly femoral bushings catalog#: 150477, lot# 378090.Oss poly tibial bushing catalog#: 150476, lot#" 438170.Palacos r 1x40 single catalog#: 00111214001, lot#: 87794709.Palacos rg 1x40 single catalog#: 00111314001, lot#: 87424699.Oss reinforced yoke catalog#: 150493, lot#: 113520.Oss mod tib baseplate 71mm catalog#: 150422, lot#: 993770.Oss tib blk aug 10x71/75 univ catalog#: 150427, lot#: 683320.Oss tibial poly bearing 16mm catalog#: 150412, lot#: 380610.Palacos rg 1x40 single catalog#: 00111314001, lot#: 89344763.Oss axle catalog#: 150480, lot#: 336910.Oss cemented im stem 12mmx90mm catalog#: 150361, lot#: 092530.Oss poly lock pin catalog#: 150478, lot#: 210660.H3: customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2024-00494, h3 other text: not returned by hospital.

Event Description

It was reported patient underwent a revision procedure five years post implantation due to femoral loosening.Attempts to obtain additional information have been made; however, no more is available at this time.

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.H6: mechanical (g04) - stem.Reported event was confirmed by review of x-rays provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.X-ray review indicates there is hinged prosthesis right total knee arthroplasty with significant loosening of the femoral component.Osteopenia is present.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: OSS CEMENTED IM STEM
• 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: 18761448
• MDR Text Key: 336052540
• Report Number: 0001825034-2024-00496
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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: 150370
• Device Lot Number: 067110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female