MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SM SPDL WITH PINS 400LBF; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item 178406 lot 445710; item 178716 lot 528700; item 178540 lot 487990; item 178527 lot 730840; item 178512 lot 025940.Foreign (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2021-00349.

Event Description

It was reported that the patient had a total knee arthroplasty and four months after the procedure subsequently was revised due to implant fracture.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: CPS SM SPDL WITH PINS 400LBF
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11294190
• MDR Text Key: 230752329
• Report Number: 0001825034-2021-00350
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304509054
• UDI-Public: (01)00880304509054(17)300403(10)235640
• Combination Product (y/n): N
• PMA/PMN Number: K101475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• 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: 178353
• Device Lot Number: 235640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention