MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM LINER 28 X 38MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 110010242- g7 osseoti 3 hole shell 48mm c- 6768309; 110024461- g7 dual mobility liner 38mm c- 838550; 51-105150- tprlc xr t1 pps 15x150mm- 3406258; 010000998- g7 screw 6.5mm x 25mm- 6690498; 010000999- g7 screw 6.5mm x 30mm- 6736389; 010000997- g7 screw 6.5mm x 20mm- 6633152; 12-115111- cer bioloxd mod hd 28mm +3 nk- 2971501.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.

Event Description

It was reported during total hip arthroplasty the wrong size implant was in the box and implanted.The surgeon will consult with the patient on best course of action forward.The procedure had a 5-minute delay, most due to what they thought was working soft tissue out of the way of the bearing.No effect on the patient due to delay.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: a1; a2; a3; b1; b2; b3; b5; d7; d11; g4; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a manufacturing deficiency.A corrective action was initiated for further investigation and root cause determination.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

It was reported the patient underwent a hip revision approximately 2 months post-implantation due to the wrong size implant being implanted.No further event information available at the time of this report.

• Brand Name: VIVACIT-E DM LINER 28 X 38MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10501764
• MDR Text Key: 205926143
• Report Number: 0001822565-2020-03177
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024572676
• UDI-Public: (01)00889024572676
• Combination Product (y/n): N
• PMA/PMN Number: K190656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

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 Model Number: N/A
• Device Catalogue Number: 110031009
• Device Lot Number: 64755636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention