MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 47 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products :zimmer liner cat#00500104728, lot#64514376.Zimmer head cat#00801802802, lot#64079516.Zimmer stem cat#00811400000, lot#64536383.Foreign report source: (b)(6).Reported event was confirmed with x rays provided.The review concluded a right total hip arthroplasty with likely malposition of the acetabular cup which has horizontal orientation.There are no signs of fracture, radiolucency, or anatomical anomalies.There is normal bone mineralization.Review of the 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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00134.0002648920 - 2020 - 00135.

Event Description

It was reported the patient underwent tha.Subsequently, patient was revised approximately 2 days later due to dislocation.The cup, liner, and head were removed and replaced.No further event information available at the time of this report.

• Brand Name: SHELL 47 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9879942
• MDR Text Key: 190767685
• Report Number: 0002648920-2020-00185
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2020

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: 00500104700
• Device Lot Number: 64417588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2019
• 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