MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS ANCHOR PLUG 10MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2022

Event Type  Injury  

Event Description

It was reported that during drilling of the transverse pin, the tip part broke into the patient and the broken piece remains in the patient body.The patient has not experienced any complications since the initial surgery.No revision surgery is planned.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.

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.H6: mechanical (g04) - drill.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Surgical notes were not provided.X-ray review by mmi states that the visualized portion shows normal fit and alignment.Bone quality appears normal.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CPS ANCHOR PLUG 10MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13869614
• MDR Text Key: 287831045
• Report Number: 0001825034-2022-00641
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304259690
• UDI-Public: (01)00880304259690(17)300110(10)917460
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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: 178400
• Device Lot Number: 917460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• 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
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose