MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CMPL F&A 5CC END 11GAX120MM; BONE GRAFT DELIVERY KIT

Catalog Number 514.503

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  Injury  

Event Description

It was reported that during a procedure the product would not mix.The case was aborted, and the patient did not receive treatment.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3008812173-2022-00004.Concomitant medical products: item#514.503; lot#209519521a03.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.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.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The reported event is for scp procedure, where 2 kits were both unable to mix as required and the procedure was postponed.As neither kit was able to be mixed as required, no injection was performed and the event was postponed; thus no adverse event or patient harm occurred.The initial report was forwarded in error and should be voided.

Event Description

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

• Brand Name: CMPL F&A 5CC END 11GAX120MM
• Type of Device: BONE GRAFT DELIVERY KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15607181
• MDR Text Key: 301748615
• Report Number: 3008812173-2022-00003
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205376
• UDI-Public: (01)00889024205376(17)240723(10)209519521B05
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 514.503
• Device Lot Number: 209519521B05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female