MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM BEARING 28X46MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 01/14/2022

Event Type  Injury  

Event Description

It was reported that the patient became dislocated and could not be reduced through closed reduction.Had to open and found femoral head became disassociated from dm poly liner.Dm construct removed and freedom construct put in place.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: cat#11-301302 ; arcos con sz b std 60mm; lot#360360.Cat#11-300808; arcos 18x150mm spl tpr dist; lot#221260.Cat#650-1064; cer option type 1 tpr sleve -6; lot#3032903.Cat#650-1055; cer bioloxd option hd 28mm; lot#3062495.Cat#110024465; g7 dual mobility liner 46mm g; cat#371300.Cat#00625006535; bone scr 6.5x35 self-tap; lot#j6851898.Cat#00625006535; bone scr 6.5x35 self-tap; lot#j6851905.Cat#110010267; g7 osseoti multihole 58mm g; lot#6512782.The device will not be returned for analysis, as the device was requested but not returned by hospital; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.A review of the device history records identified no related 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.

• Brand Name: VIVACIT-E DM BEARING 28X46MM
• Type of Device: PROSTHESIS, HIP
• 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: 13481301
• MDR Text Key: 285769930
• Report Number: 0001822565-2022-00379
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024572713
• UDI-Public: (01)00889024572713(17)260505(10)65016432
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190656
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• 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: 110031013
• Device Lot Number: 65016432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female