MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INSERTER FOR USE WITH 58 MM O.D. CUP; HIP INSTRUMENT

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #unknown unknown stem lot #unknown, item #unknown unknown head lot #unknown, 00151505848 ¿ maxera cup ¿ 64203943.Report source: (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to off label use of the product.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: 0001822565 - 2019 - 03008.Product location is unknown.

Event Description

It was reported that during an initial total hip arthroplasty, upon implanting the maxera shell and liner, the cup was not properly assembled with the inserter and the ceramic liner chipped on impaction.The surgeon had to ream to a larger size and a secondary shell and liner were used to complete the procedure.Additional information was requested however, none was available.

• Brand Name: INSERTER FOR USE WITH 58 MM O.D. CUP
• Type of Device: HIP INSTRUMENT
• 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: 9643097
• MDR Text Key: 176836782
• Report Number: 0001822565-2020-00389
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• 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: 00151601058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention