MAUDE Adverse Event Report: ZIMMER, INC. MAXERA CUP IMPACTOR; ZIMMER HIP INSTRUMENT

Model Number N/A

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the impactors had hair line cracks in them.This was discovered in the warehouse and no patient injuries or delays in procedure were reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

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.

• Brand Name: MAXERA CUP IMPACTOR
• Type of Device: ZIMMER HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): .; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6188776
• MDR Text Key: 62854673
• Report Number: 0001822565-2016-04727
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00151603036
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: 12/22/2017; 12/10/2018
• Supplement Dates FDA Received: 12/22/2017; 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1