MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SHORT ANCHOR PLUG 16MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 178538 046990 compress centering sleeve.178710 698200 locking cap and screw.150483 275220 diaphysial stacking adaptor.178366 151420 short anti rotation spindle.Foreign country: (b)(6).The device will not be returned for analysis, as the device location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the implant of oss compress system fractured.Patient noticed a cracking noise when walking.The patient was revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.X-ray reviewed confirms fracture of proximal femoral implant is confirmed with varus alignment noted.No implant loosening seen, bone quality is osteopenic.No other concerns or abnormalities.Review of device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

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: type of investigation - device not returned is n/a which was reported on initial report.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows the shaft is fractured off.Further evaluation of device states that the device fractured due to fatigue and semi-quantitative elemental analysis of the sample showed that the composition was consistent with ti-6al-4v alloy.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause cannot be determined.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: CPS SHORT ANCHOR PLUG 16MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14989023
• MDR Text Key: 295723038
• Report Number: 0001825034-2022-01609
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K062998
• 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,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 178558
• Device Lot Number: 727390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 08/19/2022; 04/04/2023
• Supplement Dates FDA Received: 08/23/2022; 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization