MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS CEMENTED IM STEM 12X150; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Date 12/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 150354 - oss 7cm segmental femoral rt - 705420 150461 - oss 3cm ellip diaphyseal seg - 187630 00223200418 - cable cerclage cable with crimp 1.8 mm dia.635 mm length - 64957282 184784 - series a pat thn 31 3 peg - 339190 161043 - oss non-mod tib plate long 71 - 658840 150410 - oss tibial poly bearing 12mm - 050800 150476 - oss poly tibial bushing - 173220 150493 - oss reinforced yoke - 688150 150477 - oss poly femoral bushings - 330920 150478 - oss poly lock pin - 025020 150480 - oss axle - 911840 g2 : foreign country : australia customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: (b)(4).

Event Description

It was reported that the patient underwent an initial knee procedure.Approximately 2.5 years post-op, the patient was revised due to loosening of the femur after a soft tissue injury.Attempts have been made and all available information has been provided.

Manufacturer Narrative

H6 : mechanical (g04) - stem no product was returned or pictures provided; visual and dimensional evaluations could not be performed.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 were not provided.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: OSS CEMENTED IM STEM 12X150
• 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: 18397114
• MDR Text Key: 331363050
• Report Number: 0001825034-2023-03042
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304238847
• UDI-Public: (01)00880304238847(17)280824(10)268820
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123501
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 150366
• Device Lot Number: 268820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose