MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PE BIPOLAR LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: unknown shell, pn unknown, ln unknown.Multiple mdr reports were filed for this event, please see associated reports 0001822565-2019-02732.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a liner was unable to be placed into multipolar shell during surgery.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, b5, d6, d7, g4, h10.Corrected b1: event was previously reported as a serious injury.No serious injury has been reported as a result of this event.Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed by review of product return.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the manufacturing process caused by deburring material left on the tool that performs the cut of the chamfer feature, and the operator not following procedure instructions.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: PE BIPOLAR LINER
• 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
• MDR Report Key: 8746929
• MDR Text Key: 149619210
• Report Number: 0002648920-2019-00467
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2019
• 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: 00500104428
• Device Lot Number: 64171398
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention