MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER MULTIPOLAR SHELL; HIP PROSTHESIS

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(6).Concomitant medical products: item # 00500104426 bipolar liner lot # 63317577.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2018-00112, 00113.

Event Description

It was reported that during surgery, the liner and cup would not mate.The surgeon used alternative products, which decreased one size from the original size to complete the surgery.Attempts have been made, and no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.As returned, the locking ring of the shell showed damage around the tabs.The liner was damaged / gouged in multiple locations.The markings and indentations on the outer radius of the liner are consistent with impaction attempts of the liner against the metal tabs of the shell's locking ring.A trial fit was performed - the devices assembled as intended.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: ZIMMER MULTIPOLAR SHELL
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 7273815
• MDR Text Key: 100429243
• Report Number: 0002648920-2018-00112
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00500104400
• Device Lot Number: 63767298
• Other Device ID Number: (01) 00889024115293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1