MAUDE Adverse Event Report: ZIMMER, INC. INSERTER FOR USE WITH 62 MM O.D. CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint number corresponding to this medwatch is (b)(4).It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that the instrument fractured.No patient involvement was reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: it was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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 information available.

Manufacturer Narrative

This follow-up report is being filled to relay a additional information, which was unknown at the time of the initial medwatch.The following sections were updated: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A 62mm maxera cup inserter was returned for evaluation and confirmed the reported instrument damage.As returned, there were no features fractured and no fracture damage was seen.Both anti-rotation pins have disassembled and are missing.The device shows wear & tear that indicates successful use during field use.The plug gage set was used accordingly and performed as per print specifications.Review of device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event.Root cause was not 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: INSERTER FOR USE WITH 62 MM O.D. CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6595891
• MDR Text Key: 76134317
• Report Number: 0001822565-2017-03587
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/11/2018

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: 00151601062
• Device Lot Number: 61913479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: 01/05/2018; 07/25/2018; 12/11/2018
• Supplement Dates FDA Received: 02/01/2018; 08/22/2018; 12/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2011
• 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