MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL SIZE GH 10 MM; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 08/14/2023

Event Type  malfunction  

Event Description

It was reported the insert trial broke during the procedure.There was no delay and there was no reported patient impact.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10   h6-component code- suggested code: provisional top visual examination of the returned product identified sign of use and it was fractured.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Medical records were not provided.Complaint is confirmed based on the product evaluation.The root cause of the reported issue is attributed to wear and tear resulted from repeated use.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: ARTICULAR SURFACE PROVISIONAL SIZE GH 10 MM
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17691705
• MDR Text Key: 322749532
• Report Number: 0001822565-2023-02433
• Device Sequence Number: 1
• Product Code: HWT
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596104210
• Device Lot Number: 60813907
• 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: 08/16/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Male