MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FEMORAL STEM CALCICOAT CERAMIC COATING SIZE 9; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00784801300 m/l kinectiv strt neck p 61269206, 0100181500 durom metasul hd 50 cde p 2472890, 0100185146 hd adapt m/0 12/14 18/20 2514226, 0100214056 durom cup 56/p 289 2477612.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product was retained by the hospital and it's location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent an initial tha and was revised ten years later due to pain and femoral stem fracture.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Radiograph review concludes that there is linear lucency involving the junction of the femoral neck and femoral stem, consistent with an incomplete fracture.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: MODULAR FEMORAL STEM CALCICOAT CERAMIC COATING SIZE 9
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9880394
• MDR Text Key: 186509484
• Report Number: 0001822565-2020-00951
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 65771300900
• Device Lot Number: 61487872
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2020
• 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
• Patient Weight: 112