MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS 3CM RESURFACING RT; 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 cemented im stem 16x150 catalog # 150370 lot # 067110 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: 0001825034-2024-00496 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were h6: mechanical (g04) - femur.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.

Event Description

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

• Brand Name: OSS 3CM RESURFACING RT
• 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: 18761395
• MDR Text Key: 336021770
• Report Number: 0001825034-2024-00494
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141331
• 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

• 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: 151805
• Device Lot Number: 462860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female