MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS RS 7 CM MOD SEG FMRL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).(b)(4).Concomitant medical products: oss rs 7 cm mod seg fmrl; p/n: 161011, l/n: 665670, diah seg lock screw set; p/n: 150481, l/n: 583850.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted.The investigation is in process and once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11237, 0001825034 - 2018 - 11238.Remains implanted.

Event Description

It was reported that the patient underwent an initial total knee arthroplasty.During the procedure, the locking screw would not insert into the femoral component.Subsequently, the device was implanted without the locking screw.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated and the reported event was confirmed.Photograph provided shows that the locking screw did not fit through the bore of the femoral component.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was attributed to a manufacturing deficiency as the product feature was not machined per print; the complaint is being reviewed through the capa process.A summary of the investigation has been sent to the complainant.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 RS 7 CM MOD SEG FMRL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8156199
• MDR Text Key: 130099710
• Report Number: 0001825034-2018-11237
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K051479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• 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: 161011
• Device Lot Number: 665670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 68