MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS RS NON-MOD PLATE SHORT 55; PROSTHESIS, KNEE

Model Number N/A

Device Problems Corroded (1131); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Reaction (2414)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown compress, unknown custom expandable, unknown augment.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04629, 0001825034 - 2019 - 04630, 0001825034 - 2019 - 04632.

Event Description

It was reported that the patient had been implanted with a femoral compress expandable system on an unknown date.X-rays have identified that the device has fractured, and metallosis has been seen during previous expansion surgeries.The patient's skin has turned gray in color due to this malfunction.The reported indicates that the patient will be undergoing a revision in the near future.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

It was reported that approximately 4.5 years post implantation, the patient was revised due to fracture of the femoral component.Metallosis was also seen throughout the joint capsule, as well as tibial loosening.The tibial loosening was not an anticipated event, and thus resulted in a 2 hour delay in surgery due to removal of the device.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: cp114845, femoral component, lot # 728940.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04629.

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.The complaint samples were evaluated, however, only the metallosis could be confirmed.The returned devices showed no evidence of fracture or significant wear.Functional testing was performed, which also produced no evidence of breakage or that the product did not perform as intended.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 RS NON-MOD PLATE SHORT 55
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9192384
• MDR Text Key: 162650667
• Report Number: 0001825034-2019-04631
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K021260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 161017
• Device Lot Number: 264560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention